Quality Engineering Manager, GMP Facility & Utilities

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

Benefits offered by this job

Pension Plan Plus

Discount platforms

Staff restaurant

Free sports activities

Job summary

Bachem AG is expanding with a new Sisslerfeld manufacturing site in Northwestern Switzerland. The QE Manager Facility & Utility Systems will ensure GxP compliance across design, commissioning, and qualification of HVAC, Cleanrooms, Clean Utilities, and related systems throughout the project lifecycle.

You will drive quality performance, support regulatory readiness, and collaborate with cross-functional teams to ensure a robust, compliant site from design through operation.

Qualifications

• Minimum 3 years of experience in pharmaceutical CAPEX projects involving HVAC, Cleanrooms, Clean Utilities, Media, and Process Gases.
• Qualification and validation expertise for process systems used in API manufacturing.
• Knowledge of regulatory requirements for qualification and validation of computerized systems, process systems, and water systems.

Responsibilities

• Ensure GMP compliance and regulatory requirements across design, commissioning and qualification stages.
• Provide Quality Engineering oversight for facility, utility, HVAC systems, Cleanrooms, Clean Utilities, Media and Process Gases, and computerized systems.
• Review and approve qualification, validation, and quality risk management documentation.
• Support DQ/IQ/OQ/PQ, process validation, and cleaning validation activities.
• Ensure qualification readiness and compliance of critical facility and utility systems.
• Manage quality-related deviations, change controls, and QMS improvements.
• Support regulatory inspections and customer audits during operations.
• Drive compliance, quality performance and continuous improvement with cross-functional teams.

Skills

C&Q and CSV knowledge

Process systems validation

Regulatory compliance knowledge

KNEAT Gx familiarity

English proficiency

Education

University or University of Applied Sciences degree in Engineering/Chemistry/Pharmacy

Job description

Bachem AG is expanding with a new Sisslerfeld manufacturing site in Northwestern Switzerland. The QE Manager Facility & Utility Systems will ensure GxP compliance across design, commissioning, and qualification of HVAC, Cleanrooms, Clean Utilities, and related systems throughout the project lifecycle.

You will drive quality performance, support regulatory readiness, and collaborate with cross-functional teams to ensure a robust, compliant site from design through operation.