The Principal Engineer leads engineering, qualification, and validation efforts for process equipment and facilities within the Fill & Finish pilot plant
Job Summary
The Principal Engineer leads engineering, qualification, and validation efforts for process equipment and facilities within the Fill & Finish pilot plant.
This role requires strong leadership in managing Base CAPEX projects while ensuring strict adherence to GMP compliance and Annex 1/FDA regulations.
Candidates will drive efficiency and business results by evaluating new technologies and optimizing aseptic manufacturing processes.
Matching Summary
The Principal Engineer leads engineering, qualification, and validation efforts for process equipment and facilities within the Fill & Finish pilot plant.
Skills & Requirements
Must-have
Process engineering and qualification
Aseptic fill finish environment expertise
GMP compliance and validation support
Root cause analysis and troubleshooting
Base CAPEX project management
Change control system management
Nice-to-have
Agile decision making skills
Lean supply chain management experience
Disruptive innovations mindset
Coaching and training capabilities
Crisis management proficiency
Key Requirements
8-10 years pharmaceutical/food/chemical experience
Bilingual German and English proficiency
Strong knowledge of aseptic fill finish operations