Quality Engineering Manager: Facility & Utilities (GMP)

Bachem Holding AG; Aargau; Remote; CHF 140.000 - 190.000; Vollzeit

Benefits dieser Stelle

Internal development

Pension plan 60%

Discount platforms

Staff restaurant

Sports activities

Zusammenfassung

Bachem Holding AG in Sisslerfeld invites you to join as QE Manager Facility & Utility Systems. You will ensure GMP/compliance for HVAC, Cleanrooms, Clean Utilities, Media and Process Gases through design, commissioning and qualification across the project and operational lifecycle.

You will lead CQV activities, review validation docs, manage deviations, support inspections, and drive continuous improvement with cross-functional teams. Fluent English required; German an advantage.

Qualifikationen

• C&Q and CSV experience with GMP-compliant validation.
• 3+ years in pharmaceutical CAPEX projects (HVAC, Cleanrooms, Clean Utilities, Media, Gases).
• Regulatory knowledge for qualification/validation of computerized and process systems.

Aufgaben

• Ensure GMP compliance throughout all project phases (design to operational).
• Provide Quality Engineering oversight for facility, utility, HVAC, Cleanrooms, and related systems.
• Review and approve qualification, validation, and quality risk management documents.

Kenntnisse

C&Q/CSV

HVAC

Cleanrooms

Process Gases

Project management

Analytical thinking

Ausbildung

Engineering/Chemistry/Pharmacy degree

Tools

KNEAT Gx

Jobbeschreibung

Bachem Holding AG in Sisslerfeld invites you to join as QE Manager Facility & Utility Systems. You will ensure GMP/compliance for HVAC, Cleanrooms, Clean Utilities, Media and Process Gases through design, commissioning and qualification across the project and operational lifecycle.

You will lead CQV activities, review validation docs, manage deviations, support inspections, and drive continuous improvement with cross-functional teams. Fluent English required; German an advantage.