Quality Engineering (QE) Manager Facility & Utility Systems - Sisslerfeld (a) 100%

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

Quality Engineering (QE) Manager Facility & Utility Systems - Sisslerfeld (a) 100%

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com .

The Bachem Group is investing in a new planned site in Sisslerfeld in Northwestern Switzerland. This step is part of the long-term strategy to expand production capacity by the end of the decade. The new production site will play a central role in achieving these goals. The designphase of the project offers you unique opportunities to shape the future organization.

As part of the development of our new Sisslerfeld manufacturing site, we are looking for a QE Manager Facility & Utility Systems. In this key role, you will ensure the GxP compliance of the design, commissioning and qualification of HVAC systems, Cleanrooms, Clean Utilities, Media and Process Gases throughout the entire lifecycle of these systems during project and operational phase.

• Ensure GMP compliance and implementation of regulatory requirements throughout all project phases from design until operational phase.
• Provide Quality Engineering oversight for facility, utility, HVAC systems, Cleanrooms, Clean Utilities, Media and Process Gases as well as for 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 and utility systems, including computerized systems.
• Manage quality-related deviations, change controls, and QMS improvement activities.
• Support regulatory inspections and customer audits during operational phase, ensuring continuous inspection readiness.
• Drive compliance, quality performance, and continuous improvement in collaboration with cross-functional stakeholders.

Your profile

• University degree or University of Applied Sciences degree in Engineering, Chemistry, Pharmacy, or a related scientific discipline.
• Strong knowledge of Commissioning & Qualification (C&Q) and Computer System Validation (CSV), including a minimum of 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.
• Thorough understanding of regulatory requirements related to qualification and validation of: Computerized systems, Process systems, Purified water systems Cleanrooms including ASTM E2500, EU GMP Guidelines, Annexes 1, 11 and 15, PIC/S Guidelines, ICH requirements, FDA regulations, and related standards.
• Knowledge of electronic validation systems such as KNEAT Gx is considered an advantage.
• High level of commitment and strong sense of ownership for both the project and the organization.
• Enthusiasm for building and establishing a new GMP manufacturing site with a pioneering mindset.
• Strong verbal and written communication skills.
• Excellent organizational skills, with the ability to prioritize tasks and manage multiple activities simultaneously to support smooth site operations, particularly during the project phase.
• Strong problem-solving skills with the ability to quickly identify issues, think analytically, and develop pragmatic solutions to overcome challenges effectively.
• Flexibility and adaptability, recognizing that priorities and responsibilities may change from one project phase to another.
• Fluent English communication skills, both written and spoken; German language skills are an advantage.

Our offer:

• A dynamic and rapidly growing work environment with internal development opportunities
• Employee development through numerous internal and external training opportunities
• 60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus
• Access to the benefits platforms with discounts from external partners
• Fresh, healthy and varied food in our staff restaurant
• A wide range of free sports activities on the Bachem Campus

Would you like to shape global Operational Readiness frameworks with us?

Learn more about the Bachem Group and our working environment at the Stein site on our website.

At Bachem, you’ll find a diverse, multicultural team. The (a)in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation.