Senior Commissioning & Qualification Engineer Sisslerfeld , 100%
Core
Leading Commissioning & Qualification (C&Q) activities for large-scale CAPEX investment projects in a new Swiss biopharma manufacturing site, ensuring GMP compliance and smooth handover to operations.
Role type
Senior Commissioning & Qualification Engineer (IC)
Builds
New GMP manufacturing facilities and automation systems for peptide and oligonucleotide production
Domain
Biopharmaceuticals / Life Sciences / GMP Manufacturing
Required skills
C&Q expertise (Biologics, Small molecules, GMP/Non-GMP infrastructure, Automation), International CAPEX project management, GMP/Regulatory knowledge (FDA, EMA, ICH, ISPE), Risk management, Team leadership, Budget & schedule control
Preferred skills
KNEAT Gx experience, Lean & agile methodologies, Supplier evaluation, Global standard harmonization
Technologies
KNEAT Gx, ISPE Integrated Commissioning & Qualification
Responsibilities
Lead C&Q activities in multidisciplinary investment projects, Manage C&Q deviations and changes within timelines, Ensure smooth handover to operations and quality, Manage and train C&Q teams including external partners, Collaborate globally to harmonize C&Q standards, Conduct technical reviews in CAPEX projects
Seniority
Senior, hands-on IC with strategic project leadership
