Job Description

The Rahway FLEx (Formulation Laboratory & Experimentation) Center is a flexible, agile facility that brings together capabilities, operations, and talent to accelerate the pipeline—

Pharmaceutical Operations & Clinical Supply is seeking applicants for a Manufacturing Engineering Lead to support specialty dosage forms and oral solid dosage (OSD) GMP development activities on second shift. The successful incumbent will serve as the technical lead for shift production, coordinating safety, quality, and equipment decisions. This role evaluates safety, product/process quality, and equipment performance and determines the appropriate path forward to protect patients, people, and compliance.

Key Responsibilities

• Own technical decisions for the shift and act as the primary production engineering point of contact for Non‑Sterile operations.
• Evaluate safety, quality, and equipment status; make real‑time technical determinations on next steps, including stop‑work when risk warrants; escalate and document per cGMP expectations.
• Serve as owner and trainer for key equipment with emphasis on specialty setups (e.g., spray drying, autoinjector assembly, potent‑processing isolators).
• Lead room readiness and equipment readiness: plan/execute room setup; equipment assembly/disassembly; cleaning; line clearance; changeover.
• Author, execute, and close GMP documentation (batch records, logs, investigations, CAPA, change controls); ensure data integrity in MES (e.g., PAS‑X) and ALCOA principles.
• Troubleshoot equipment/system issues and drive root‑cause analysis with peer specialists, formulation scientists, facility engineers, and automation engineers; implement robust corrections/preventive actions.
• Coach and develop the shift team by actively sharing knowledge, standardizing best practices, and identifying improvements that strengthen safety, quality, delivery, and cost.
• Lead improvement activities on one of the specialty equipment trains in the oral solid dosage facility
• Champion Ways of Working and continuous improvement; lead small projects from scoping through qualification and handover.
• Approves equipment disposition (repair, replace, optimize) based on condition, reliability, and product requirements; coordinates with Maintenance/Facilities, Automation, production, process engineering and formulators.

Minimum Qualifications

• Bachelor’s degree in Engineering or Science (e.g., Mechanical, Chemical, Biomedical) or equivalent GMP manufacturing experience.
• 5+ years in GMP clinical or commercial manufacturing (OSD or specialty dosage forms) with hands‑on equipment setup, cleaning, and troubleshooting.
• Demonstrated knowledge of cGMP, data integrity, batch documentation, investigations, and CAPA.
• Experience with OCT, FCT and encapsulation manufacturing; spray dryers, autoinjector assemblies, isolators (OEB4/OEB5), or comparable specialty equipment.
• Strong problem solving and root‑cause analysis skills; ability to lead and train operators/technicians on the floor.
• Ability to work second shift on‑site in classified GMP suites.

Preferred Qualifications

• MES experience (e.g., PAS‑X) and proficiency with electronic logbooks and quality systems.
• Exposure to potent compound handling and containment strategies; respirator/gowning certification a plus.
• Lean/Six Sigma certification or practical application; familiarity with TPM/RCM and basic reliability tools.
• Working knowledge of EHS risk assessment (JSA/WRAs) and equipment qualification/validation basics.

eligibleforERP

NSBE2026

PSCS

FLEx2026

Required Skills:

Adaptability, Analytical Testing, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, Good Manufacturing Practices (GMP), Process Design, Process Hazard Analysis (PHA), Process Optimization, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving, Technical Writing

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

2nd - Evening

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/29/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Senior Scientist, Discovery Chemistry

Our Company is seeking exceptional chemists for positions within the Discovery Chemistry Department. The successful candidate will join multidisciplinary, highly collaborative discovery teams to invent novel medicines by applying innovative synthetic chemistry, analytical techniques, and data analysis to design and synthesize drug candidates and intermediates. In addition, you’ll have the opportunity to expand your knowledge and skills through collaborations with talented and dedicated colleagues while advancing your career.

Specific responsibilities will include the following:

• Act as an expert in the laboratory, executing on program and chemistry strategy.
• Develop and utilize innovative synthetic, medicinal chemistry and/or chemical biology problem solving skills coupled with analysis of diverse data sets to build structure-activity relationships.
• Design, synthesize, purify, and characterize drug candidates and/or chemical probes in target identification and validation, hit-to-lead, and lead optimization programs.
• Provide scientific mentoring and technical training of team members.
• Establish a substantial external scientific presence including authoring significant scientific publications and presentations.

To accomplish the above, the successful candidate must be a creative and innovative scientist with strong organic synthesis, problem solving, interpersonal, collaboration and communication skills.

Required Education:

• B.S in chemistry, medicinal chemistry, or related scientific discipline with seven (7) years’ experience, M.S. in related fields with four (4) years’ experience, or a Ph.D. in related fields (received by Summer 2026) with 0-2 years’ experience.

Required Experience and Skills:

• Extensive experience in organic synthesis with emphasis on methodology/catalysis, total synthesis, and/or physical organic chemistry.
• Ability to solve complex problems.

Required Skills:

Accountability, Adaptability, Analytical Method Development, Chemical Proteomics, Chemical Synthesis, Chemometrics, Chromatography, Data Analysis, Data-Driven Decision Making, Flow Cytometry, Machine Learning (ML), Mass Spectrometry Based Proteomics, Motivation Management, Process Analytical Technology (PAT), Protein Chromatography, Spectroscopy, Synthetic Biology

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$131,400.00 - $206,800.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

04/30/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Associate Director, Raw Material & Release Management

Within Planning and Manufacturing Systems (PAMS) in our Research Division's Bioprocess Clinical Manufacturing and Technology (BCMT), the Associate Director, Raw Material & Release Management (P4) is the single accountable lead for end-to-end management of raw materials, culture media/buffers, excipients, single-use components, and GMP supplies that support pilot-scale GMP manufacture of clinical biologic bulk (vaccines, therapeutic proteins, monoclonal antibodies). Based in the Biologics Pilot Plant (BPP) / VAX PR&D environment, this role combines advanced materials planning and procurement with release management, validated system stewardship, and cross‑functional leadership to ensure compliant, timely, and cost‑effective material readiness for multiple clinical campaigns.

The role operates at the intersection of Manufacturing, Process Development, Quality/Release, Procurement, Manufacturing and Research divisions network, Biological Support Operations (BSO), and external suppliers. The Associate Director is responsible for strategy and execution across sourcing, inventory, release, documentation, and continuous improvement, and will represent material readiness risks and mitigations to senior stakeholders.

Key Responsibilities:

• Own end‑to‑end lifecycle for raw materials, culture media/buffers, excipients, single‑use components and GMP supplies for pilot‑scale clinical bulk manufacturing: forecasting, prioritization, sourcing (internal Manufacturing and Research divisions and external vendors), procurement, receiving, storage, distribution, and disposition.
• Lead release activities: author/review release documentation, coordinate testing submissions and lab turnaround, and ensure timely product availability for clinical campaign timelines.
• Manage validated systems and data integrity for release and inventory workflows (SAP, RLIMS2, Veeva, MEDS): define requirements, support enhancements, and act as SME liaison between end users and Quality.
• Translate regulatory and quality expectations (cGMP, CFR, data integrity/ALCOA+) into procedures and system controls; partner with Quality to define acceptance criteria, manage deviations/CAPAs, and support filings/audits.
• Coordinate culture media/buffer manufacture (internal and external): forecasting, scheduling, batch documentation, and lead laboratory studies with Process Development when required to define critical parameters.
• Maintain and optimize inventory visibility and storage capacity (including single‑use), implement replenishment strategies, and drive mitigation plans for shortages, supplier issues, or quality holds.
• Author and enforce SOPs, release protocols, work instructions, and change‑control documentation using validated repositories and tools.
• Lead cross‑functional projects: develop charters/scopes/schedules/resource plans/risk registers/budgets; manage vendors, run status meetings, and report KPIs and risks to stakeholders.
• Provide production support: coordinate incident management for material shortages or release failures, perform root cause analysis, and implement corrective/preventive actions with Quality and Procurement.
• Drive continuous improvement initiatives to reduce lead times, improve inventory turns, reduce cost, and enhance compliance (Lean/Six Sigma principles).
• Mentor and provide technical guidance to planners and release staff; participate in network benchmarking and standardization across sites.
• Must be available for occasional off‑shift or overtime work to support critical campaign execution.

Education Requirements:

• BS, MS, or MBA degree in Engineering or Biological Sciences with a minimum of 7 years of relevant experience within the Pharmaceutical or Biopharmaceutical industry.

Required Experience and Skills:

• Demonstrated experience in raw material planning/procurement and inventory management for GMP manufacturing is required, with SAP experience.
• Proven experience in release management for raw materials and culture media, including generation and review of release documentation, coordination with testing laboratories, and disposition decisions, is essential.
• Serve as primary point of contact for Supplier Change Notifications: track, review, assess impact, coordinate supplier/internal mitigation or qualification activities, and document outcomes in change‑control systems.
• Practical experience with validated systems and document repositories (for example RLIMS2, SAP, Veeva, MEDS)
• The candidate must have strong knowledge of regulatory requirements governing clinical supply manufacture and release (cGMP, CFR) and data integrity best practices.
• The role requires proven project management and stakeholder management skills—scope, schedule, resource, risk and issue management—and comfort reporting to senior stakeholders.
• Excellent analytical, problem‑solving skills, strong attention to detail, advanced Excel capabilities, and strong interpersonal and communication skills capable of influencing cross‑functional teams in a fast‑paced environment are also required.
• The candidate must be able to work effectively in a dynamic environment where priorities constantly shift, quickly reprioritizing tasks and decisions to support time-sensitive clinical manufacturing campaigns.

Preferred Qualifications:

• Preferred experience includes work in biologics pilot-scale or aseptic manufacturing supporting clinical campaign timelines, experience managing single-use technology inventory and supply chains, and experience with supplier qualification and vendor management for biological raw materials.
• Formal training or certification in Lean/Six Sigma, PMP, or GAMP is desirable.
• Experience supervising or mentoring staff and leading cross-functional teams is preferred.

PRD #PRD

Required Skills:

Adaptability, Adaptability, Chemical Engineering, Customer-Focused, Data-Driven Decision Making, Data Integrity, Drug Product Development, Estimation and Planning, GMP Compliance, Inventory Management, Manufacturing Quality Control, Monoclonal Antibodies, Pharmaceutical Process Development, Polyclonal Antibody Production, Process Control Automation, Process Optimization, Procurement, Product Formulation, Production Support, Project Management, Release Documentation, Release Management, Safety Compliance, Stakeholder Management, Strategic Thinking {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

04/29/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Job Description:

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile. The FLEx Sterile facility is poised to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide, encompassing a diverse range of product modalities, including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs). The FLEx organization has a mission to enable development of our Company’s pipeline products with speed, agility, and rigor. This mission will be accomplished by: 1) Enabling robust formulation and process development with flexible physical and digital infrastructure; 2) Delivering compliant, high quality clinical supplies; 3) Developing talents with a new operating model and promoting a growth mindset. As the facility nears completion of its Process Simulation execution, this presents an exciting opportunity for individuals eager to learn, demonstrate themselves, and grow with a rapidly expanding team.

The FLEx organization is seeking a highly motivated individual to serve the role of Senior Specialist, Technical Operations Engineer, reporting to the Technical Operations Lead. The successful candidate will support routine operations through timely troubleshooting of production equipment issues, establishment of new processes and implementation of continuous improvement projects with goals to reduce operation cycle time, errors, and costs. This individual will collaborate closely with the Production, New Product Introduction, Facilities, Equipment, Automation and Quality teams to ensure compliant, right first time execution and timely delivery of business goals. The role is on-site, based in Rahway, NJ and will support our second shift operations which operate from 3:30 PM EST to 12AM EST. Due to the nature of second shift operations, flexibility and overtime may be required occasionally to coordinate with personnel from first shift. Occasional weekend work may also be required to support operations.

Education Minimum Requirements:

• BS or MS in Chemical Engineering, Mechanical Engineering, Biomedical Engineering or related engineering field with a minimum of 5 years of relevant experience.

Required Experience and Skills:

• Subject Matter Expertise in various sterile processing equipment such as automated filling lines, lyophilizers, autoclaves, part washers, isolators and etc.
• Knowledge of automation systems such as PLC, DCS, and MES.
• Knowledge of Drug Product processing aseptic processing techniques.
• Experience in leading and supporting quality investigations of deviations and change management.
• Familiarity with United States and European Union GMP and Safety compliance regulations.
• Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.
• Possesses effective project management skills to drive process improvement.  Able to communicate clearly business/compliance driver, develop and manage project plan to meet deliverables, and escalate issues with meeting objectives to avoid schedule impact.
• Strong technical aptitude and critical thinking skills to effectively troubleshoot and resolve issues on the production floor.
• Possess and leverages strong working knowledge of theories, practices, and procedures to train others efficiently.  Applies knowledge to improve processes.
• Familiarity with common Drug Product processing unit operations such as mixing, filtration, temperature control and etc.
• Lean Six Sigma Green Belt certification.
• Effective interpersonal and communication skills, both verbal and written. Able to cultivate and leverage working relationships with stakeholders within department as well as across the organization.
• Excellent organizational skills to multi-task.
• Desire and willingness to learn, contribute and lead.
• Track-record of independent problem-solving.

Preferred Experience and Skills:

• Experience with Commissioning, Qualification and Validation of equipment.
• Understanding of ISA88 and ISA95 principles.
• Knowledge of Investigational drug regulatory requirements.
• Understanding of Clinical Supply Chain Operations.
• Lean Six Sigma Black Belt certification.

PSCS

eligibleforERP

FLEx2026

Sterile2026

NSBE2026

Required Skills:

Adaptability, Adaptability, Analytical Testing, Antibody Drug Conjugates (ADC), Biomedical Engineering, Biopharmaceuticals, Critical Thinking, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, Good Manufacturing Practices (GMP), Improvement Projects, Job Descriptions, Machine Troubleshooting, Mechanical Engineering, Medical Supply Management, New Product Development, Process Design, Process Hazard Analysis (PHA), Process Optimization, Project Planning, Root Cause Analysis (RCA), Standard Operating Procedure (SOP) Development, Strategic Thinking {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

2nd - Evening

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/30/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

The Associate Director, Maintenance provides operational leadership and technical oversight of maintenance activities for the sterile product manufacturing site. In this role, the Associate Director ensures equipment reliability, safe work practices, and regulatory compliance while supporting production needs and continuous improvement initiatives.

In addition, this role will support the development and execution of the site’s Integrated Facilities Management (IFM) strategy and will actively participate throughout the project life cycle in Factory Acceptance Tests (FATs) for utilities, facilities, and process equipment to ensure maintainability, reliability, and lifecycle considerations are incorporated into equipment and system design.

Key Responsibilities

• Capital Projects & Equipment Lifecycle Support

• Participate as the maintenance representative in major capital project design, execution, and start-up, with primary emphasis on start-up readiness—ensuring maintenance strategies, CMMS build-out, spare parts, diagnostic capabilities, SOPs, training, and reliable systems turnover are fully in place prior to qualification and initial manufacturing—along with participation in future capital equipment installations and small- to mid-scale upgrade projects, coordinating contractors and internal resources under engineering or project management leadership.

• Attend and actively participate in utility, facility, and process equipment Factory Acceptance Tests (FATs) throughout the project life cycle.

• Provide maintenance and reliability input during FATs to ensure:

• Maintainability and accessibility are considered

• Spare parts strategies are optimized

• Standardization, diagnostics, and serviceability are aligned with site practices

• Support equipment turnover to maintenance, including documentation review, CMMS asset setup, and maintenance strategy development.

Maintenance Operations & Leadership

• Oversee day-to-day maintenance operations for assigned production areas, including preventive, predictive, and corrective maintenance activities.
• Supervise, coach, and develop maintenance staff; ensure adherence to safe work practices and OSHA/GMP requirements.
• Coordinate maintenance priorities with production, quality, and engineering teams to minimize downtime and support production schedules.
• Ensure accurate and timely execution and documentation of maintenance activities within the CMMS.
• Maintain key maintenance performance metrics for assigned areas and communicate operational status to site leadership.

Integrated Facilities Management (IFM) Support

• Support the development, deployment, and ongoing execution of the site IFM strategy in alignment with site leadership objectives.
• Serve as a key maintenance interface with IFM service providers, ensuring alignment with maintenance standards, safety expectations, and GMP requirements.
• Participate in defining maintenance scopes of work, service-level expectations, and performance metrics related to IFM services.
• Support monitoring of IFM performance and identification of continuous improvement opportunities at the operational level.

Reliability & Continuous Improvement

• Implement and sustain preventive and predictive maintenance tasks as defined by site strategy and reliability programs.
• Support troubleshooting and root-cause analysis for major equipment or system failures; coordinate corrective actions with engineering and subject-matter experts.
• Apply Lean and continuous improvement principles at the area or equipment level to reduce downtime and improve maintenance efficiency.
• Support reliability improvement initiatives by providing operational insights on equipment performance and maintainability.

Compliance & Regulatory Readiness

• Ensure all maintenance activities comply with GMP requirements, safety regulations, and site procedures.
• Prepare, maintain, and provide maintenance records and documentation to support internal reviews and regulatory inspections.
• Support inspection readiness activities by ensuring assigned areas meet compliance and documentation expectations.

Qualifications

Required

• Bachelor’s degree in Engineering, Facilities Management, or a related technical field with
• Seven (7) years of maintenance experience in pharmaceutical or biotech manufacturing; sterile manufacturing experience strongly preferred.
• At least three (3) years in a supervisory or team-lead role with responsibility for maintenance technicians or supervisors.
• Practical experience with CMMS, preventive maintenance, and predictive maintenance programs.
• Familiarity with GMP, safety regulations, and industry standards applicable to sterile manufacturing.
• Proven experience troubleshooting process equipment and coordinating corrective actions with cross-functional teams.
• Working knowledge of Lean principles or continuous improvement methods.
• Strong communication skills and ability to collaborate across production, quality, engineering, and facilities teams.

Preferred

• Experience with potent compound manufacturing
• Experience supporting or interfacing with Integrated Facilities Management (IFM) organizations.
• Experience participating in or supporting FATs, SATs, and equipment qualification activities.
• Exposure to predictive maintenance technologies (vibration analysis, ultrasound, thermography) or coordination with Predictive Maintenance (PdM) service providers.
• Demonstrated ability to develop, coach, and retain maintenance technicians.

Required Skills:

Adaptability, Adaptability, Capital Projects, Computerized Maintenance Management Systems (CMMS), Corrective Action Management, Corrective Maintenance, Digital Transformation, Documentation Review, Driving Continuous Improvement, Facility Management, GMP Compliance, HVAC Systems, Maintenance Documentation, Maintenance Management, Maintenance Strategy, Occupational Health and Safety Management, People Leadership, Predictive Maintenance, Preventative Maintenance Programs, Preventive Action, Process Control Systems, Regulatory Compliance, Reliability Engineering, Safety Leadership, Technical Writing {+ 1 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/2/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Our Digital Manufacturing Operations Team supporting our vibrant West Point site is seeking a Process Automation Engineer Specialist to join their Team. This role will provide automation system support and expertise to enable our manufacturing division in the reliable and compliant supply of quality vaccine products to customers and patients across the globe.

Responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations. Actively support, participate and embrace a diverse and inclusive culture including significant interaction with manufacturing, quality and engineering groups. Supports a broad spectrum of automated systems within GMP Manufacturing Operations.

General responsibilities include:

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
• Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Provide automation system support and expertise to assist the manufacture of quality vaccine products to meet site priorities.
• Responsible and accountable for supporting all automation system components of the processes including on the shop floor support of manufacturing activities
• Responsible for designing, implementing, testing, and closing-out change controls for automation related corrective actions and continuous improvement initiatives.
• Build relationships with functional counterparts and stakeholders in the business to proactively. identify and resolve technical issues.
• Lead or participate in investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions.
• Stay current with latest automation technologies and trends and make recommendations for adoption
• Provide off-site weekend/evening automation phone or on-site support for our 24/7 manufacturing operations.

Skill Requirements:

• Strong communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment

Preferred Skills:

• Experience in GMP Manufacturing - pharmaceutical/ biotechnology industry.
• Familiarly with Computer system validation and regulatory GXP requirements.
• Aseptic processing/sterile manufacturing experience.
• Technical and operational expertise in the DeltaV DCS, Allen-Bradley PLC, SCADA, HMI ASi/Field/Profibus or other related technologies.
• Networking, Virtual Machines, Database management and other general IT administration.
• Experience with data analytics tools (e.g. Spotfire, PowerBI)

Education Requirements:

• BS in Engineering, Computer Science or related field with 2 years of experience (GMP Manufacturing and/or Manufacturing Automation)
• Or
• High School Diploma and with 4 years of experience (GMP Manufacturing and/or Manufacturing Automation)

MSJR

VETJOBS

Required Skills:

Data Management, GMP Compliance, Good Manufacturing Practices (GMP), Manufacturing Processes, Process Control, Process Manufacturing, Real-Time Programming, Regulatory Requirements, Software Development Life Cycle (SDLC), TIBCO Spotfire

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$87,300.00 - $137,400.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/1/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

At our company, we are dedicated to advancing the prevention and treatment of diseases in people and animals through innovative health solutions. We are seeking a passionate and experienced Associate Director of Engineering to join our team. This role offers a unique opportunity to contribute to the development of cutting-edge biologic and vaccine drug substances, drug products, and medical device combination products. If you are driven by the power of leading-edge science and want to make a meaningful impact on global health, we invite you to apply.

Responsibilities:

• Provide technical expertise from initial design concept through product launch with a primary focus on biologic and vaccine drug substances, drug products, and medical device combination products (MDCPs).
• Influence oral solid dosage form packaging design as needed based on complexity.
• Understand considerations of complex packaging design and the interplay between product and package.
• Identify and mitigate risks through structural and materials design optimization.
• Collaborate with other engineers to influence the data-driven development of packaging systems for sterile and non-sterile products.
• Upskill fellow packaging engineers on risk-based experimental design and data analysis.
• Build inclusive, collaborative partnerships with internal and external stakeholders.
• Display ownership and proactively identify opportunities to build technical rigor into standard work and packaging platforms.
• Drive the right risk posture that balances technical probability, cost and resources, and trade-offs across various groups.
• Navigate complex situations in a fast-paced environment while aligning packaging with product and patient needs.

Education Requirements:

• Bachelors degree (B.S./B.A) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with ten (10) years of relevant pharmaceutical development experience; OR
• Master of Science (M.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with eight (8) years of relevant pharmaceutical development experience; OR
• PhD in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with five (5) years of relevant pharmaceutical development experience.

Required Experience and Skills:

• Large molecule autoinjector design experience
• End-to-End experience in packaging of pharmaceutical and/or medical device/combination products.
• Knowledge of current US and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging.
• Experience with a variety of primary, secondary, and tertiary packaging types common in the biopharmaceutical industry.
• Use of design and modeling tools to enhance understanding of distribution stresses and packaging dynamics.
• Ability to determine interrogate the science, identify true requirements, and proactively detect critical flaws.
• Leadership skills to enable collaboration with diverse business partners.
• Ability to drive complex projects to completion in a fast-paced environment.
• Ability to navigate ambiguity, embrace experimentation and learning, and model a growth mindset.
• Ability to identify technical capability gaps and influence other engineers.
• Excellent technical written and oral communication skills.
• Proficient in problem solving, risk-based decision-making, and use of standard work.
• Ability to maintain subject matter expertise and help the organization grow and learn in packaging development.

Preferred Experience and Skills:

• Background in application of numerical design and modeling tools.
• Quality by Design (QbD) experience.
• Experience in defining standard work processes and documents.
• Experience specifying, processing, and characterizing packaging materials.
• Expertise in hypothesis development and testing, statistical analysis, and Design of Experiments.
• Lean Six Sigma or Design for Six Sigma certification.

This document contains AI-generated content.

Required Skills:

Biologics, Combination Products, Compliance Packaging, Engineering Standards, Good Manufacturing Practices (GMP), Injection Devices, Leadership, Manufacturing Scale-Up, Packaging Engineering, Process Optimization, Root Cause Analysis (RCA), Technical Leadership

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$129,000.00 - $203,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/27/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Applications are sought for a senior specialist position in our Research & Development Division's Biologics Pilot Plant (BPP) automation engineering group.  Individual will lead and perform various automation activities supporting pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies.

Candidate will participate in a range of activities including, but are not limited to:

• Technically lead ongoing automation system support in the facility
• Provide automation expertise for GMP clinical manufacturing campaigns in the facility
• Lead and/or execute the design, scope, implementation, and GMP close out of pilot plant projects including the specification and automation integration of new equipment, upgrades and improvements
• Author and review GMP change controls, test protocols, SDLC documentation, SOP’s, safety reviews, deviation investigations and actions
• Lead ongoing maintenance and upgrade projects for automation systems in the facility
• Work with the team to innovate and evaluate new technologies and automation systems to improve the pilot plant’s reliability and increase efficiency
• Cross train in many areas and technologies
• Actively work in a multi-discipline cross-functional project team environment

In addition to the core responsibilities outlined above, an opportunity exists to collaborate across our Research & Development Division with automation and digital initiatives and to contribute towards defining/streamlining various business processes for efficient and flexible GMP clinical supply for products in all phases of development. Some off shift (second shift and weekends) will be required to support campaigns.  

Education Minimum Requirement:

Bachelor’s degree in engineering or computer science with a minimum of 5 years of relevant automation experience.

Required Experience and Skills:

• Highly motivated with the ability to work in a fast-paced and dynamic setting.
• Strong organizational, planning, and communication skills.
• Previous automation experience supporting GMP production of pharmaceuticals, biopharmaceuticals, or vaccines.  This includes executing GMP change controls.
• Significant experience in one or more of the following automation technologies:  DeltaV, Ignition, PLC/SCADA.
• Ability to work independently and in a team environment

Desired Experience and Skills:

• Experience with manufacturing equipment, process control, automation infrastructure design, and/or cybersecurity
• Experience with integrating equipment automation systems with Enterprise IT managed systems (e.g. MES, virtualization, networking, windows and antivirus patching/updates)
• Experience with Project Management Methodologies (Agile, Waterfall, etc) and Tools (Jira/Confluence, RACI, GANTT)

Required Skills:

Adaptability, Analytical Testing, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, Good Manufacturing Practices (GMP), Process Design, Process Hazard Analysis (PHA), Process Optimization, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving, Technical Writing

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

04/27/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Applications are being sought for an Engineering Specialist position in our Company's Research & Development division Biologics Pilot Plant (BPP) automation engineering group.  Individual will perform various automation activities supporting pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies.

Candidate will participate in a range of activities including, but are not limited to:

• Providing ongoing automation system support and executing projects in the facility, with progression to leading those projects
• Participating in the design, scope, implementation, and maintenance of pilot plant projects
• Actively working in a multi-discipline project team environment
• Developing and maintaining SDLC documentation.
• Participating/leading in the troubleshooting of various automation system technologies
• Participating/leading in upgrade and ongoing maintenance projects on systems in the facility.
• Cross training in a variety of technologies
• Supporting automation needs across the facility
• Working with the team to innovate and evaluate new technologies and automation systems to improve the pilot plant’s reliability and increase efficiency

In addition to the core responsibilities outlined above, an opportunity exists to contribute towards digital initiatives to support efficient and flexible GMP clinical supply for products in all phases of development. Some overtime (including weekends) and occasional second shift work may be required.  

Education Minimum Requirement:

• Bachelor’s degree in engineering or computer science with at least 2 full years of relevant experience, or at least 1 year of experience with a master’s degree.

Required Experience and Skills:

• Previous experience with industrial automation system configuration or programming at a production or lab scale
• Strong organizational, planning, and communication skills
• Ability to work both in a team setting and independently

Desired Experience and Skills:

• Experience in a GMP regulated industry
• Knowledge in any of the following: Systems communication/integration, DeltaV, Ignition, PLC’s, Unicorn, manufacturing IT, process/system control, systems communication (interfaces)
• Experience with production equipment

Required Skills:

Adaptability, Adaptability, Automation Engineering, Automation Framework Design, cGMP Guidelines, Computer Science, Electronic Batch Records, GMP Compliance, Industrial Automation, Innovation, Laboratory Experiments, Mammalian Cell Culture, Manufacturing, Medical Supplies, Personal Initiative, Pilot Plant Operations, Process Engineering, Process Optimization, Product Development, Product Formulation, Product Lifecycle, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing, Systems Troubleshooting, Teamwork {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$87,300.00 - $137,400.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

04/27/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Welcome to the Future of Precision Oncology – Join Us in Wilmington, DE!

We’re thrilled to announce the launch of our cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware—a bold step forward in transforming cancer care through innovation, collaboration, and purpose-driven science. This is more than a job - it’s a chance to be part of the next wave of cancer care. Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute to life-changing therapies for patients around the world. Together, we’ll build a facility that not only meets the highest standards of safety and innovation but also fosters a culture of excellence, inclusion, and impact.

Join us in Wilmington and help shape the future of cancer treatment—one molecule at a time.

In this position the Technical Operations Associate Director will play a pivotal role in ensuring oversight of various aspects of manufacturing, change management and technology transfer of programs to the site. In partnership with site manufacturing team will provide comprehensive manufacturing and technical leadership to the DS organization supporting the continued build, commissioning and qualification. This position will continue within the role from design through operation of the facility.

Responsibilities

• Lead and engage with the engineering design firms in detailed design on all aspects of drug substance manufacturing.
• Lead and drive the Process Hazard Analyses and Quality Risk Assessments as necessary.
• Active participation in factory acceptance testing (FAT) and site acceptance testing (SAT).
• Develop project appropriate guidance documents as necessary.
• Execute automation sprints as necessary in the drug substance area.
• Support equipment qualification deliverables including equipment Commissioning & Qualification, IOQ, etc.
• Creation, review and revision of technical documents including manufacturing batch records, SOPs and technical memos.
• Provide Manufacturing and Technical expertise to the manufacturing team and leadership of the Technical Operations team, including areas such as conjugation, chromatography, tangential flow filtration and filling.
• Oversee the Engineering Batches, Process Performance Qualifications and commercial manufacturing including authoring relevant filing sections.
• Provide technical leadership for new product introductions (Tech Transfer).
• Support technical deliverables within Drug Substance to support the successful product launch.
• Provide manufacturing and technical support for RFT implementation and execution.
• Communicate complex technical issues to stakeholders, external customers, agencies.

Qualifications

Required

• Bachelor’s degree in engineering, science or related discipline.
• Eight or more (8+) years working in a cGMP biological, vaccine or pharma facility.
• Demonstrated ability to lead and operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
• Previous experience of manufacturing and technical support of shakedown batches engineering batches, developmental batches and PPQ runs.
• Ability to adapt to changing priorities as project demands change.
• Demonstrated skills in planning, communication (oral and written) and technical writing.

Preferred

• Start-up experience in a large-scale commercial drug substance facility highly desirable with hands-on experience with antibody drug conjugates highly preferred.
• Expertise in chromatography and TFF operations will be advantageous.
• Previous experience with CQV activities will be advantageous.
• Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma.
• Experience in a risk-based approach to manufacturing through use of tools such as FMEA.

Required Skills:

Antibodies, Antibodies, Antibody Drug Conjugates (ADC), API Manufacturing, Change Control Systems, Change Request Management, Chemical Process Development, Chromatography, Cross-Cultural Awareness, Cross-Functional Teamwork, Detailed Design, Deviation Management, Equipment Qualification, Factory Acceptance Test (FAT), GMP Compliance, Hazard Analysis, Immunochemistry, Manufacturing, Manufacturing Process Validation, Operational Acceptance Testing (OAT), People Leadership, Process Optimization, Production Supervision, Regulatory Inspections, Regulatory Requirements {+ 8 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/5/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.