Associate Director, Engineering; Hybrid

Position: Associate Director, Engineering (Hybrid)
*
* Location:

** Rahway, New Jersey  
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* Reports to:

** FLEx Sterile Compliance Lead, Pharmaceutical Operations & Clinical Supply
* 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.
* 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.
* 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
** 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
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