Downstream QE Manager — GMP Site Readiness & Compliance

Bachem AG; Stein (AR); On-site; CHF 140,000 - 190,000; Full time

Benefits offered by this job

Pension plan

Staff restaurant

Fitness facilities

Professional development

Job summary

Bachem AG is expanding with a new Sisslerfeld manufacturing site in Northwestern Switzerland. We seek a QE Manager Downstream to provide quality oversight across startup to commercial manufacturing, ensuring compliant, robust systems and regulatory readiness.

The role requires deep C&Q/CSV knowledge, pharma CAPEX project experience, and a proactive, cross-functional leader with strong communication. English is essential; German is advantageous. Join a pioneering team building a new GMP site.

Qualifications

• Strong knowledge of Commissioning & Qualification (C&Q) and Computer System Validation (CSV).
• Minimum of three years of experience in pharmaceutical CAPEX projects related to downstream processing.
• Qualification and validation expertise for process systems used in API manufacturing.
• Regulatory requirements for qualification/validation of computerized systems, lab instruments and process systems.

Responsibilities

• Ensure GMP compliance and implementation of applicable pharmaceutical regulations throughout the project lifecycle.
• Review and approve Qualification Master Plans, URS, System Impact Assessments, and Quality Risk Assessments.
• Provide Quality Engineering oversight for C&Q including DQ, IQ, OQ, and PQ and associated validation activities.
• Support design, qualification readiness, and compliance of manufacturing systems (buffer, chromatography, ultrafiltration, freeze drying).
• Conduct design reviews and manage deviations, change controls, and system release activities.
• Oversee calibration/maintenance for equipment, facilities, lab instruments, computerized systems, and analytical methods.
• Ensure GMP compliance during the Operational Phase and support audits/regulatory inspections.

Skills

Communication

Organizational skills

Problem solving

English proficiency

Education

Engineering/Chemistry/Pharmacy degree

Tools

KNEAT Gx

Job description

Bachem AG is expanding with a new Sisslerfeld manufacturing site in Northwestern Switzerland. We seek a QE Manager Downstream to provide quality oversight across startup to commercial manufacturing, ensuring compliant, robust systems and regulatory readiness.

The role requires deep C&Q/CSV knowledge, pharma CAPEX project experience, and a proactive, cross-functional leader with strong communication. English is essential; German is advantageous. Join a pioneering team building a new GMP site.