Equipment Engineer Parenteral Pilot Plant
Core
Design, install, commission, and qualify pharmaceutical manufacturing equipment for parenteral and solid dosage forms in a clinical pilot plant setting.
Role type
Equipment Engineer (Pharmaceutical Pilot Plant)
Builds
Clinical manufacturing supplies for new drug products (small and large molecules)
Domain
Pharmaceutical manufacturing / Parenteral and Solid Dosage Forms
Required skills
GMP compliance, equipment qualification (IQ/OQ/PQ), risk assessment (HAZOP, FMEA), project management, technical documentation, supplier coordination, troubleshooting, process integration
Preferred skills
Experience with fill-finish equipment, autoclaves, lyophilizers, steam sterilization, ATEX regulations, Microsoft Project
Technologies
GMP, HAZOP, FMEA, Microsoft Project, FAT/SAT protocols
Responsibilities
Translate process needs into technical equipment solutions, lead investment projects from concept to qualification, support construction and commissioning, participate in change control and risk assessments, build technical expertise in parenteral manufacturing equipment
Seniority
Mid-level, hands-on IC