Downstream Quality Engineering Manager - GMP Validation

Bachem Holding AG; Stein; On-site; CHF 140,000 - 190,000; Full time

Benefits offered by this job

Pension fund 60% coverage

Employee discounts

Staff restaurant

Campus sports

Internal training opportunities

Job summary

Bachem Holding AG is expanding its Sisslerfeld site and seeking a QE Manager Downstream to ensure GMP-compliant, inspection-ready manufacturing systems from startup to commercial scale. You will partner with cross-functional teams to deliver robust quality oversight across C&Q activities.

The role emphasizes qualification, validation, and continuous improvement within a pioneering, high-growth project environment at the new site in Northwestern Switzerland.

Qualifications

• Extensive experience with C&Q and CSV in pharma CAPEX projects.
• Experience with downstream processing: chromatography, ultrafiltration, drying.
• Knowledge of regulatory guidelines (EU GMP, ICH, FDA).

Responsibilities

• Ensure GMP compliance across the project lifecycle.
• Review qualification, validation and quality risk management documentation.
• Provide Quality Engineering oversight for C&Q activities (DQ/IQ/OQ/PQ).
• Support design, qualification readiness, and compliance of manufacturing systems.
• Oversee calibration, maintenance and validation of equipment and lab instruments.
• Support audits and regulatory inspections; drive QMS effectiveness.

Skills

C&Q knowledge

CSV expertise

Quality oversight

GMP regulations

Cross-functional collaboration

Education

University degree in Engineering

Chemistry or Pharmacy degree

Tools

KNEAT Gx

Job description

Bachem Holding AG is expanding its Sisslerfeld site and seeking a QE Manager Downstream to ensure GMP-compliant, inspection-ready manufacturing systems from startup to commercial scale. You will partner with cross-functional teams to deliver robust quality oversight across C&Q activities.

The role emphasizes qualification, validation, and continuous improvement within a pioneering, high-growth project environment at the new site in Northwestern Switzerland.