Process Engineer – Biotech Manufacturing Scale (USP/DSP)

About the role

We are seeking a hands‑on Process Engineer to support commercial‑scale GMP biologics production in Switzerland. The position focuses on upstream (USP) and downstream (DSP) operations at 2,000‑20,000 L scale, acting as the shop‑floor subject‑matter expert for real‑time troubleshooting of process and equipment issues.

Key responsibilities

• Support and oversee large‑scale GMP biotech manufacturing processes (USP/DSP) in commercial production.
• Ensure reliable batch execution and act as the on‑site SME for real‑time troubleshooting.
• Lead deviation investigations, perform root‑cause analysis, and implement CAPA.
• Review batch records, ensure GMP compliance, and support process validation activities (PPQ, cleaning validation, CPV).
• Collaborate with Production, QA, MSAT, Engineering & Maintenance teams.
• Support equipment qualification activities (FAT/SAT) and technical assessments.
• Contribute to continuous‑improvement initiatives and train operators as needed.

Required profile

• Bachelor’s or Master’s degree in Bioprocess Engineering, Biotechnology, Chemical Engineering or a related field.
• Minimum 3 years of experience in a validated cGMP pharmaceutical or bioprocessing environment.
• Fluent English and German.

Required skills

• Bioreactors
• Chromatography skids
• Filtration
• Ultrafiltration/Diafiltration (UF/DF)
• CIP/SIP systems
• Process validation (PPQ, cleaning validation, CPV)
• Equipment qualification (FAT/SAT)
• Deviation investigation and root‑cause analysis
• CAPA implementation
• GMP compliance

What we offer

• Opportunity to work on challenging, large‑scale biotech projects with leading industry clients.
• Access to training through accredited and certified centers.
• Supportive local management team and a dynamic, values‑driven work environment.
• Stable, long‑term employment within a well‑established Swiss operation.