Staff Process Engineer PAR NPI/LCM
Core
Introducing new parenteral products into commercial production and implementing new technologies and processes in line with technology transfer plans.
Role type
Staff Process Engineer (New Product Introduction & Life Cycle Management)
Builds
Drug product filling processes for parenterals
Domain
Pharmaceutical manufacturing (Innovative Medicine)
Required skills
Technology transfer, GMP compliance, Change control management, Process validation, Batch execution (clinical/validation), Regulatory filing support, SAP/PAS-X systems, Liquid formulation filling, Biotechnological API handling, Cost improvement projects
Preferred skills
Master's degree, 4+ years pharma experience, Late-stage development knowledge, Unit operations (compounding/milling), German fluency
Technologies
SAP, PAS-X
Responsibilities
Execute engineering, clinical, and validation batches; Lead process robustness and compliance improvement projects; Manage change controls and document updates; Train shop floor teams; Serve as subject matter expert for audits and inspections.
Seniority
Staff, hands-on IC with strategic oversight
