Specialist, Engineering (Onsite)
Core
Specialist Engineer supporting sterile drug product clinical supply manufacturing operations, including formulation, filling, lyophilization, and visual inspection across Durham, NC and Rahway, NJ sites.
Role type
Specialist Engineer (Pharmaceutical Manufacturing)
Builds
Sterile clinical drug product supplies for clinical trials
Domain
Pharmaceutical manufacturing (Sterile/GMP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, equipment troubleshooting, change controls, equipment validation, technical protocol authoring, deviation investigation, root cause analysis, CAPA implementation, sterilization/cleaning validation, automation system maintenance, data integrity management, project management, cross-functional collaboration
Preferred skills
Project management, cross-functional leadership, change control, deviation management, technical writing, sterile process manufacturing, formulation development
Technologies
Electronic Batch Records, aseptic filling equipment, lyophilization systems, automation systems, OT/IT architecture
Responsibilities
Author quality investigations, change controls, SOPs, and technical protocols; execute commissioning, qualification, and regulatory certification of GMP facilities; lead sterilization and cleaning validation programs; maintain GMP-compliant facilities and equipment using reliability practices; manage automation system lifecycle, cybersecurity, and data integrity; support capital projects and new product introductions; perform manual and automated operations and troubleshooting
Seniority
Mid-level, hands-on IC
