Associate Director, Engineering (Hybrid)

Job Description

Job Title: Compliance Engineer FLEx Sterile Operations

Location: Rahway New Jersey
Reports to: FLEx Sterile Compliance Lead Pharmaceutical Operations & Clinical Supply

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 positioned to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide encompassing a range of product modalities including sterile small molecules biologics vaccines and antibody-drug conjugates (ADCs). In addition to the current robotic filler and associated processing suites poised to start GMP manufacturing this summer a large-scale capital project known as the FLEx Sterile Expansion project is underway.

The Compliance Engineer supports the FLEx Sterile Operations team in maintaining the highest standards of safety quality and regulatory compliance. The role will work closely with Operations Quality Environmental Health & Safety Regulatory Affairs Facilities Management Engineering and Analytical teams ensuring the facility remains audit- and inspection-ready and fosters a culture of continuous improvement. The Compliance Engineer will contribute to training environmental monitoring subject-matter expert (SME) development and compliance initiatives supporting the organizations overall compliance posture.

Limited off-shift (2nd) work may be expected as a part of the role to support the operations area. The role is on-site based in New Jersey and reports to the FLEx Sterile Compliance Lead within Pharmaceutical Operations and Clinical Supply (PSCS).

Primary Responsibilities:

• Lead the development maintenance and assignment of training curricula ensuring content remains current relevant and aligned with compliance requirements.

• Monitor track and report on training completion effectiveness and adoption of training technologies supporting continuous improvement.

• Monitor the facilitys environmental monitoring (EM) program including data review investigations and execution of risk assessments to maintain compliance.

• Support inspection readiness and participate in internal and external audits including GMP compliance audits and Safety/GMP walkthroughs.

• Review and assess evolving Quality Management System (QMS) documentation and procedures assessing facility alignment with regulatory and internal requirements.

• Manage SOP governance including periodic reviews and updates driven by quality or operational changes.

• Provide oversight for departmental investigations and change controls ensuring timely closure robust rootcause analysis effective action plans and CAPAs and trend monitoring.

• Oversight and further establishment of the facility Aseptic Observer Program performing observations data mining CAPA development and crossfunctional communication of results.

• Lead operational responsibilities for the PSIM program including protocol authorship execution and planning oversight management of annual qualifications and support for sterility investigations.

• Drive skills development initiatives including onboarding strategies COE/consortium participation and establishment and maintenance of competency and improvement trackers.

• Collaborate with Production QA and cross-functional teams to support compliance initiatives continuous improvement efforts and evaluation of new technologies.

Education Minimum Requirement:

• Bachelors degree in Chemical Engineering Chemistry Pharmaceutical Sciences or related scientific field with a minimum of 7 years relevant experience

• Masters degree in Chemical Engineering Chemistry Pharmaceutical Sciences or related scientific field with a minimum of 5 years of relevant experience or a

• PhD degree in Chemical Engineering Chemistry Pharmaceutical Sciences or related scientific field with a minimum of 2 years of relevant experience.

Required Experience and Skills:

• Excellent interpersonal and communication skills both written and oral.

• Proven competencies in drug product aseptic processing equipment and aseptic technique.

• Experience in change management and leading quality investigations.

• Familiarity with United States and European Union regulatory requirements and Safety compliance regulations.

• Lean Six Sigma and Root Cause Analysis experience

• Ability to author Standard Operating Procedures (SOP) and other GxP documents.

• Experience with quality systems.

• Excellent organizational skills.

• Desire and willingness to learn contribute and lead.

• Track-record of independent problem-solving.

Preferred Experience and Skills:

• Experience with C&Q facility start-up media fills environmental monitoring programs and readiness for aseptic operations.

• Lean Six Sigma Certification

• Teamwork and people development skills

#PSCS

#eligibleforERP

FLEx2026

Sterile2026

Required Skills:

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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 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

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 employees 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 can apply for this role through (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

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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.

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