Associate Director, Engineering - Sterile Production Lead
Merck, Rahway, NJ, United States
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). A large‑scale capital project, known as the FLEx Sterile Expansion project, is currently underway and will more than double the facility’s capacity by adding a second clinical filling/lyophilization suite, a formulation suite, a sterile supply suite, and supporting infrastructure.
As the facility transitions from C&Q into routine operations, the Associate Director, Engineering will own operational readiness, leading SOP deployment, media fills, EM program readiness, cleaning/disinfection validation, scheduling and production control, and readiness drills. They will also own a performance system driving safety, quality, delivery, cost, and people metrics, leveraging lean methodologies and digital tools to continuously improve throughput and reliability.
Key Responsibilities
Build and lead the Operations organization from inception, including recruiting, staffing plans, role design, onboarding, and capability development.
Partner with engineering, validation, and quality to align operational requirements with C&Q activities; ensure equipment and facilities are released for GMP use and ready for clinical campaigns.
Establish and maintain GMP‑compliant operating procedures, standard work, and training programs for aseptic manufacturing, materials management, and facility operations.
Serve as the system owner for process equipment within the filling, formulation, and sterile supply suites—emphasis on the filling line, filling isolator, and lyophilizer.
Own operational readiness: SOP deployment, media fills, EM program readiness, cleaning/disinfection validation, scheduling, and production control.
Lead daily operations post‑authorization, including production execution, scheduling, material flow, inventory controls, and collaboration with partner groups for tech transfers.
Implement an operational excellence system: tiered daily management, visual performance boards, KPI tracking (safety, quality, delivery, cost, people), deviation reduction, and continuous improvement.
Ensure robust compliance with cGMP, aseptic processing standards, data integrity, and regulatory expectations for clinical manufacturing.
Drive cross‑functional coordination with Quality, Technical Operations, EHS, Supply Chain, and Program Management to deliver on clinical timelines and batch release commitments.
Manage capacity planning, scenario modeling, and resource allocation to meet clinical demand and portfolio priorities.
Establish a culture of safety, empowerment, and accountability; lead with clarity, transparency, and a focus on patient impact.
What Success Looks Like
Facility transitions from C&Q to cGMP operations on schedule, with flawless execution of containment verification, media fills, and audit readiness activities.
A fully staffed and trained operations team performs with high reliability, compliance, and morale.
Standard work and SOPs are deployed and adhered to; deviations and interventions trend downward quarter‑over‑quarter.
Clinical batches are delivered on time, at an acceptable yield, with robust quality outcomes.
Continuous improvement pipeline is active and measurable, driving gains in throughput, cycle time, and cost without compromising quality or safety.
Manufacturing and operational expertise is applied in sterile supply, formulation, isolators, filling, lyophilization, capping, and visual inspection.
Ability to solve complex problems, take new perspectives with a desire to continuously learn, and involve appropriate stakeholders.
All work activities are conducted with strict adherence to safety and compliance culture.
Support the authoring of electronic batch records, sampling plans, and SOPs.
Education Minimum Requirements
Bachelor’s degree in business, engineering, pharmaceutical sciences or related field with a minimum of 8 years of relevant experience.
Master’s degree with 6 years of relevant experience, or a PhD degree with 4 years of relevant experience.
Required Experience And Skills
Proven leadership experience in aseptic drug product manufacturing operations within GMP‑regulated environments; clinical or early‑stage operations experience strongly preferred.
In‑depth technical and operational knowledge of aseptic filling lines, isolators, and lyophilizers.
Demonstrated success in building and scaling operations teams, including hiring, training, and developing frontline and leadership talent.
In‑depth understanding of cGMP, aseptic processing principles, contamination control strategies, and data integrity requirements.
Strong command of operational excellence methodologies (Lean, Six Sigma), daily management systems, and KPI‑driven leadership.
Effective cross‑functional collaboration and communication skills; ability to translate complex technical requirements into clear operational plans.
Preferred Experience And Skills
Hands‑on experience with C&Q, facility start‑up, media fills, environmental monitoring programs, and readiness for aseptic operations.
Consultative skills: ability to influence decision‑making, interact with all levels of the business.
Project management skills (demonstrated experience managing large project teams).
Ability to lead and drive Process Hazard Analyses and Quality Risk Assessments as necessary.
Required Skills
Adaptability, Chemical Engineering, Customer‑Focused, Data‑Driven Decision Making, Drug Product Development, Estimation and Planning, Manufacturing Quality Control, Pharmaceutical Process Development, Process Control Automation, Process Optimization, Product Formulation, Safety Compliance, Strategic Thinking, Technical Mentoring, Technical Writing.
Preferred Skills
Current employees and contingent workers may apply.
Location Requirements
U.S. and Puerto Rico residents only.
San Francisco residents only: considered qualified applicants with arrest and conviction records for employment in compliance with the ordinance.
Los Angeles residents only: considered all qualified applicants with criminal histories consistent with state laws.
Legal and Compensation EEO Statement: We are an Equal Employment Opportunity Employer 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 legally protected characteristics.
Salary Range: $142,400.00 – $224,100.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.
Benefits: 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.
Hybrid Work Model: Employees in office‑based positions in the U.S. will follow a hybrid schedule of three on‑site days per week (Monday‑Thursday), with Friday remote, unless business critical tasks require on‑site presence. This model does not apply to facility‑based or research‑based positions.
Recruitment Details
Requisition ID: R391591
Job Posting End Date: 04/17/2026
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As the facility transitions from C&Q into routine operations, the Associate Director, Engineering will own operational readiness, leading SOP deployment, media fills, EM program readiness, cleaning/disinfection validation, scheduling and production control, and readiness drills. They will also own a performance system driving safety, quality, delivery, cost, and people metrics, leveraging lean methodologies and digital tools to continuously improve throughput and reliability.
Key Responsibilities
Build and lead the Operations organization from inception, including recruiting, staffing plans, role design, onboarding, and capability development.
Partner with engineering, validation, and quality to align operational requirements with C&Q activities; ensure equipment and facilities are released for GMP use and ready for clinical campaigns.
Establish and maintain GMP‑compliant operating procedures, standard work, and training programs for aseptic manufacturing, materials management, and facility operations.
Serve as the system owner for process equipment within the filling, formulation, and sterile supply suites—emphasis on the filling line, filling isolator, and lyophilizer.
Own operational readiness: SOP deployment, media fills, EM program readiness, cleaning/disinfection validation, scheduling, and production control.
Lead daily operations post‑authorization, including production execution, scheduling, material flow, inventory controls, and collaboration with partner groups for tech transfers.
Implement an operational excellence system: tiered daily management, visual performance boards, KPI tracking (safety, quality, delivery, cost, people), deviation reduction, and continuous improvement.
Ensure robust compliance with cGMP, aseptic processing standards, data integrity, and regulatory expectations for clinical manufacturing.
Drive cross‑functional coordination with Quality, Technical Operations, EHS, Supply Chain, and Program Management to deliver on clinical timelines and batch release commitments.
Manage capacity planning, scenario modeling, and resource allocation to meet clinical demand and portfolio priorities.
Establish a culture of safety, empowerment, and accountability; lead with clarity, transparency, and a focus on patient impact.
What Success Looks Like
Facility transitions from C&Q to cGMP operations on schedule, with flawless execution of containment verification, media fills, and audit readiness activities.
A fully staffed and trained operations team performs with high reliability, compliance, and morale.
Standard work and SOPs are deployed and adhered to; deviations and interventions trend downward quarter‑over‑quarter.
Clinical batches are delivered on time, at an acceptable yield, with robust quality outcomes.
Continuous improvement pipeline is active and measurable, driving gains in throughput, cycle time, and cost without compromising quality or safety.
Manufacturing and operational expertise is applied in sterile supply, formulation, isolators, filling, lyophilization, capping, and visual inspection.
Ability to solve complex problems, take new perspectives with a desire to continuously learn, and involve appropriate stakeholders.
All work activities are conducted with strict adherence to safety and compliance culture.
Support the authoring of electronic batch records, sampling plans, and SOPs.
Education Minimum Requirements
Bachelor’s degree in business, engineering, pharmaceutical sciences or related field with a minimum of 8 years of relevant experience.
Master’s degree with 6 years of relevant experience, or a PhD degree with 4 years of relevant experience.
Required Experience And Skills
Proven leadership experience in aseptic drug product manufacturing operations within GMP‑regulated environments; clinical or early‑stage operations experience strongly preferred.
In‑depth technical and operational knowledge of aseptic filling lines, isolators, and lyophilizers.
Demonstrated success in building and scaling operations teams, including hiring, training, and developing frontline and leadership talent.
In‑depth understanding of cGMP, aseptic processing principles, contamination control strategies, and data integrity requirements.
Strong command of operational excellence methodologies (Lean, Six Sigma), daily management systems, and KPI‑driven leadership.
Effective cross‑functional collaboration and communication skills; ability to translate complex technical requirements into clear operational plans.
Preferred Experience And Skills
Hands‑on experience with C&Q, facility start‑up, media fills, environmental monitoring programs, and readiness for aseptic operations.
Consultative skills: ability to influence decision‑making, interact with all levels of the business.
Project management skills (demonstrated experience managing large project teams).
Ability to lead and drive Process Hazard Analyses and Quality Risk Assessments as necessary.
Required Skills
Adaptability, Chemical Engineering, Customer‑Focused, Data‑Driven Decision Making, Drug Product Development, Estimation and Planning, Manufacturing Quality Control, Pharmaceutical Process Development, Process Control Automation, Process Optimization, Product Formulation, Safety Compliance, Strategic Thinking, Technical Mentoring, Technical Writing.
Preferred Skills
Current employees and contingent workers may apply.
Location Requirements
U.S. and Puerto Rico residents only.
San Francisco residents only: considered qualified applicants with arrest and conviction records for employment in compliance with the ordinance.
Los Angeles residents only: considered all qualified applicants with criminal histories consistent with state laws.
Legal and Compensation EEO Statement: We are an Equal Employment Opportunity Employer 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 legally protected characteristics.
Salary Range: $142,400.00 – $224,100.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.
Benefits: 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.
Hybrid Work Model: Employees in office‑based positions in the U.S. will follow a hybrid schedule of three on‑site days per week (Monday‑Thursday), with Friday remote, unless business critical tasks require on‑site presence. This model does not apply to facility‑based or research‑based positions.
Recruitment Details
Requisition ID: R391591
Job Posting End Date: 04/17/2026
#J-18808-Ljbffr