Merck · 6 hours ago
Associate Director, Engineering (Hybrid)
USA - New Jersey - Rahway
Full-time
Hybrid
Lead/Staff, Director/Executive
$142K/yr - $224K/yr
5+ years expMerck is a leading global healthcare company, and they are seeking a Compliance Engineer for their FLEx Sterile Operations. The role involves supporting compliance initiatives within a cutting-edge sterile drug product manufacturing facility, ensuring the highest standards of safety, quality, and regulatory compliance.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
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
Qualification
Required
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
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 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
Benefits
Medical, dental, vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital Advisors"Gavi, the Vaccine Alliance"
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-02-05
Genetic Engineering News
2026-02-05
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