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 organization's 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 facility's 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 root‑cause 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 cross‑functional 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:
- Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 7+ years relevant experience
- Master’s 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:
Accountability, Accountability, Adaptability, Antibody Drug Conjugates (ADC), Aseptic Technique, Capital Projects, Chemical Engineering, Chemistry, Compliance Implementation, Compliance Support, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Environmental Monitoring, Estimation and Planning, GMP Compliance, Innovation, Leadership, Manufacturing Quality Control, Operations Support, Pharmaceutical Process Development, Process Control Automation, Process Optimization, Product Formulation, Quality Management System Improvement {+ 5 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:
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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:
No relocation
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:
02/20/2026
- 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.
Requisition ID:R383681
