Quality Engineering Manager, Facility & Utilities

Bachem Holding AG; Stein; On-site; CHF 150,000 - 190,000; Full time

Benefits offered by this job

Development opportunities

Pension contributions

Discount platforms

Staff restaurant

Sports activities

Job summary

Bachem Holding AG is developing a new Sisslerfeld site in Northwestern Switzerland and seeks a QE Manager for Facility & Utility Systems. You will ensure GxP compliance, guide design, commissioning, and qualification of HVAC, Cleanrooms, Clean Utilities, Media and Process Gases throughout the lifecycle, and collaborate with cross-functional teams.

The role requires leading qualification activities, supporting regulatory inspections, and driving quality improvements across the site during

Qualifications

• Degree in Engineering, Chemistry, Pharmacy, or related field.
• 3+ years in pharma CAPEX projects with HVAC, Cleanrooms, Clean Utilities, Media and Process Gases.
• Qualification/validation expertise for process systems used in API manufacturing.
• Knowledge of regulatory requirements (ASTM E2500, EU GMP Annexes 1/11/15, PIC/S, ICH, FDA).
• Fluent English; German is an advantage.

Responsibilities

• Ensure GMP compliance and regulatory requirements across all project phases from design to operation.
• 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 Commissioning and Qualification (DQ/IQ/OQ/PQ), process validation, and cleaning validation activities.
• Ensure qualification readiness and compliance of critical facility/utility systems, including computerized systems.
• Manage quality-related deviations, change controls, and QMS improvement activities.
• Support regulatory inspections and customer audits during operation.
• Drive compliance, quality performance, and continuous improvement with cross-functional teams.

Skills

C&Q expertise

CSV validation

HVAC systems

GxP regulatory

Quality oversight

Documentation

Cross-functional

English fluent

Education

Engineering degree

Tools

KNEAT Gx

Job description

Bachem Holding AG is developing a new Sisslerfeld site in Northwestern Switzerland and seeks a QE Manager for Facility & Utility Systems. You will ensure GxP compliance, guide design, commissioning, and qualification of HVAC, Cleanrooms, Clean Utilities, Media and Process Gases throughout the lifecycle, and collaborate with cross-functional teams.

The role requires leading qualification activities, supporting regulatory inspections, and driving quality improvements across the site during