Associate Director, Engineering (Hybrid)

Merck•Rahway, NJ

1d•Hybrid

About The Position

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).

Requirements

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.

Nice To Haves

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

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.