Senior CSV Quality Engineering Manager

Bachem Holding AG; Stein; On-site; CHF 140,000 - 180,000; Full time

Benefits offered by this job

Pension plan

Training opportunities

Staff restaurant

Campus sports program

Partner discounts

Job summary

Bachem Holding AG in Sisslerfeld seeks a Quality Engineering (QE) Manager CSV (a) 100% to ensure compliance and quality oversight for computerized systems across their lifecycle. You will drive CSV, qualification and validation activities from design through commercial operations.

You will collaborate with cross-functional teams to ensure GMP compliance, inspection readiness and ongoing site readiness for the new manufacturing site in Northwestern Switzerland.

Qualifications

• University or engineering/chemistry/pharmacy degree.
• Minimum 3 years in pharmaceutical CAPEX CSV projects.
• Strong knowledge of regulatory requirements for CSV/QA.
• Experience with PCS7/MES, MOS and LIMS systems.
• Fluent in English; German is an advantage.

Responsibilities

• Ensure GMP compliance and implement pharma regulations across the project lifecycle.
• Review/approve qualification and validation docs (QMP, URS, SIS, QRA).
• Provide quality oversight for commissioning, qualification and IQ/OQ/PQ.
• Support design, qualification readiness and compliance of PCS7/MES, LIMS and related systems.
• Lead design reviews, manage deviations, change controls and system releases.

Skills

CSV knowledge

C&Q expertise

Regulatory knowledge

Project management

Stakeholder communication

English proficiency

German skills

Education

Engineering degree

Tools

PCS7/MES

MOS

LIMS

KNEAT Gx

Job description

Bachem Holding AG in Sisslerfeld seeks a Quality Engineering (QE) Manager CSV (a) 100% to ensure compliance and quality oversight for computerized systems across their lifecycle. You will drive CSV, qualification and validation activities from design through commercial operations.

You will collaborate with cross-functional teams to ensure GMP compliance, inspection readiness and ongoing site readiness for the new manufacturing site in Northwestern Switzerland.