Quality Engineering Manager Facility & Utility Systems - Sisslerfeld 100% in Stein

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

Bachem ist ein börsenkotiertes, auf die Peptid-Chemie fokussiertes Technologie-Unternehmen mit einem umfassenden Leistungsangebot für die Pharma- und Biotechnologie-Industrie.

Bachem ist spezialisiert auf die Entwicklung innovativer, effizienter Herstellungsverfahren und die zuverlässige Produktion Peptid-basierter pharmazeutischer Wirkstoffe.

Ein umfangreicher Katalog von Biochemikalien für Forschungszwecke und exklusive Kundensynthesen ergänzen das Angebot.

Mit Hauptsitz in der Schweiz sowie Niederlassungen in Europa und den USA ist das Unternehmen weltweit tätig und verfügt über die industrieweit grösste Erfahrung und Fachkompetenz.

In der Zusammenarbeit mit ihren Kunden legt Bachem grössten Wert auf Qualität, Innovation und Partnerschaft.

• Quality Engineering (QE) Manager Facility & Utility Systems - Sisslerfeld (a) 100%
• 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 design phase 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 Gx P 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.

• Your tasks
• 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; 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?

We look forward to receiving your complete application documents via our application portal.

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

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