Associate Director, Engineering
MSD
full-time
Posted on:
Location Type: Hybrid
Location: Rahway • New Jersey • United States
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Salary
💰 $142,400 - $224,100 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
drug product aseptic processingaseptic techniquechange managementquality investigationsLean Six SigmaRoot Cause AnalysisStandard Operating Procedures (SOP)GxP documentsquality systemsenvironmental monitoring
Soft Skills
interpersonal skillscommunication skillsorganizational skillsproblem-solvingleadershipcollaborationcontinuous improvementtraining developmentoversightdata analysis