QE Manager, Downstream - Build a New GMP Manufacturing Site

Bachem Holding AG; Schweiz; Remote; CHF 120,000 - 180,000; Full time

Benefits offered by this job

Career development opportunities

60% pension fund contributions

Partner discounts

Staff restaurant

Sports activities on campus

Job summary

Bachem Holding AG in Switzerland is seeking a QE Manager Downstream to provide quality oversight across startup to commercial manufacturing on the new Sisslerfeld site. You will partner with cross-functional teams to ensure GMP compliance, qualification and validation of systems, and robust manufacturing processes.

This role demands deep C&Q/CSV expertise, experience in pharmaceutical CAPEX projects, and strong communication skills in English (German a plus).

Qualifications

• Degree in engineering, chemistry, or pharmacy required.
• Minimum three years in pharmaceutical CAPEX projects downstream.
• Experience with qualification and validation of process systems.
• Knowledge of regulatory requirements for qualification and validation.
• Experience with electronic validation systems is a plus.

Responsibilities

• Ensure GMP compliance throughout the project lifecycle.
• Review and approve qualification, validation, and risk documentation.
• Provide Quality Engineering oversight for commissioning & qualification activities.
• Support design, qualification readiness, and compliance of manufacturing systems.
• Conduct design reviews and manage deviations, change controls, and system releases.
• Oversee qualification, calibration, maintenance of equipment and instruments.
• Ensure ongoing GMP compliance during the Operational Phase.
• Support audits and regulatory inspections.

Skills

C&Q knowledge

CSV familiarity

Quality systems validation

GMP regulatory knowledge

Cross-functional collaboration

English proficiency

German language (advantage)

Education

University degree in Engineering, Chemistry, or Pharmacy

Tools

KNEAT Gx

Job description

Bachem Holding AG in Switzerland is seeking a QE Manager Downstream to provide quality oversight across startup to commercial manufacturing on the new Sisslerfeld site. You will partner with cross-functional teams to ensure GMP compliance, qualification and validation of systems, and robust manufacturing processes.

This role demands deep C&Q/CSV expertise, experience in pharmaceutical CAPEX projects, and strong communication skills in English (German a plus).