Manufacturing Support Engineer.
General Information:
- Start Date: 01.11.2026 (candidates with notice periods will be considered)
- Workplace: Bern
- Home Office: possible, to be discussed
- Working Hours: Standard
About the job:
In this role, you’ll act as the key technical bridge between line operations, quality compliance, and process engineering. Operating directly on the shop floor, you will keep high-speed packaging and finishing lines running seamlessly while driving continuous process optimizations.
Tasks & Responsibilities:
- Line Stability & Support: Troubleshoot live operational issues and optimize high-speed finishing and parenteral packaging lines.
- Process Excellence: Apply Lean tools (FMEA, VSM) to eliminate bottlenecks, improve throughput, and reduce downtime.
- Quality & Compliance: Lead root-cause analyses (RCA), manage deviations, author CAPAs, and oversee Change Controls using platforms like TrackWise/SAP/MES.
- GMP Documentation: Draft and refine critical production records, batch documents, SOPs, and validation protocols.
- Audit & Subject Matter Expertise: Serve as a technical SME during regulatory inspections and internal quality audits.
Requirements:
- Education: MSc in Process Engineering, Bioengineering, Pharma Sciences, or a related field.
- Experience: 3 to 6+ years in a regulated biotech or pharma manufacturing environment.
- Packaging & Inspection: Hands-on experience with visual inspection processes on the packaging side.
- Operational & QA Support: Proven track record in technical troubleshooting on packaging and inspection lines, updating technical/GMP documentation, writing investigation/QA reports, and handling non-routine deviations.
- Technical Skills: Experience with liquid/parenteral packaging (vials, syringes) and GMP change management.
- Languages: Professional fluency in German (B2/C1 minimum) and English.
- Mindset: Pragmatic, proactive, and energized by working directly alongside shop-floor production teams.