QE Manager, CSV & GMP for a New Pharma Site
Bachem
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Benefits offered by this job
Job summary
Bachem is developing a new Sisslerfeld site in Northwestern Switzerland. We seek a QE Manager CSV (a) 100% to lead C&Q/CSV activities, ensure GMP compliance, and oversee qualification of computerized systems across the project lifecycle.
The role requires a degree in engineering/chemistry/pharmacy and at least three years in pharma CAPEX CSV projects, with strong communication and organizational skills in English (German is a plus).
Qualifications
- University degree in Engineering, Chemistry, Pharmacy or related field.
- Minimum of three years in pharmaceutical CAPEX projects involving CSV systems (PCS7/MES, MOS, LIMS).
- Strong knowledge of Commissioning & Qualification (C&Q) and CSV.
- Regulatory requirements: EU GMP, PIC/S, ICH, FDA, etc.
- Experience with electronic validation systems (KNEAT Gx is a plus).
- Excellent communication and organizational skills; English required; German a plus.
Responsibilities
- Ensure GMP compliance and implement pharmaceutical regulations across the project lifecycle.
- Review and approve qualification/validation docs (URS, IQ/OQ/PQ, etc.).
- Provide QA oversight for commissioning/qualification of computerized systems.
- Support design, qualification readiness, and compliance of PCS7/MES, Monitoring System, LIMS, etc.
Skills
Education
Tools
Job description
Bachem is developing a new Sisslerfeld site in Northwestern Switzerland. We seek a QE Manager CSV (a) 100% to lead C&Q/CSV activities, ensure GMP compliance, and oversee qualification of computerized systems across the project lifecycle.
The role requires a degree in engineering/chemistry/pharmacy and at least three years in pharma CAPEX CSV projects, with strong communication and organizational skills in English (German is a plus).
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