Sr. Specialist, Engineering (Onsite)

Role: Senior Operations Engineer leading construction and operational readiness for a sterile drug product manufacturing expansion at the FLEx Sterile Facility, supporting clinical supply production of small molecules, biologics, vaccines, and ADCs. Responsibilities: collaborate on equipment and facility design, system commissioning, qualification, and startup; operate aseptic manufacturing equipment; develop SOPs, training, and documentation; lead digital tool implementation for process insights; ensure compliance, safety, and quality during GMP clinical supply operations. Requirements: Bachelor's in Engineering, Science, or related field with 5+ years of GMP sterile manufacturing experience; expertise in aseptic techniques, equipment troubleshooting, GMP documentation, and process validation; proficiency with data analysis tools like MS Access, Excel, Power BI; experience with facility startup and lean principles. Preferred: automation, process engineering, continuous improvement skills. High-Value: sterile small molecules, biologics, vaccines, ADCs; clinical development stage; regulatory compliance; cross-functional collaboration with engineering, quality, and automation teams; travel up to 10% during construction and startup. Work setup: location in Rahway, NJ, with flexible hours and travel as needed.