Hybrid Associate Director, Engineering

at MSD

• Job title: Associate Director, Engineering
• Job type: Full Time
• Experience level: Senior
• Salary: $142,400 - $224,100 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Rahway, United States

About the role

• Compliance Engineer for FLEx Sterile Operations ensuring regulatory compliance and quality in pharmaceutical manufacturing. Supporting training, audits, and environmental monitoring in a state-of-the-art facility.

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.

Requirements

• 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.

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