Quality Engineering

h3Quality Engineering (QE) Manager Facility Utility Systems
- Sisslerfeld (a) 100% /h3pBachem 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 . /ppThe bBachem Group /b 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. /ppAs part of the development of our new Sisslerfeld manufacturing site, we are looking for a bQE Manager Facility Utility Systems. /bIn 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. /pulliEnsure GMP compliance and implementation of regulatory requirements throughout all project phases from design until operational phase. /liliProvide Quality Engineering oversight for facility, utility, HVAC systems, Cleanrooms, Clean Utilities, Media and Process Gases as well as for computerized systems. /liliReview and approve qualification, validation, and quality risk management documentation. /liliSupport Commissioning and Qualification (DQ, IQ, OQ, PQ), process validation, and cleaning validation activities. /liliEnsure qualification readiness and compliance of critical facility and utility systems, including computerized systems. /liliManage quality-related deviations, change controls, and QMS improvement activities. /liliSupport regulatory inspections and customer audits during operational phase, ensuring continuous inspection readiness. /liliDrive compliance, quality performance, and continuous improvement in collaboration with cross-functional stakeholders. /li /ulpbYour profile /b /pulliUniversity degree or University of Applied Sciences degree in Engineering, Chemistry, Pharmacy, or a related scientific discipline. /liliStrong knowledge of Commissioning Qualification (CQ) 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. /liliQualification and validation expertise for process systems used in API manufacturing. /liliThorough 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. /liliKnowledge of electronic validation systems such as KNEAT Gx is considered an advantage. /liliHigh level of commitment and strong sense of ownership for both the project and the organization. /liliEnthusiasm for building and establishing a new GMP manufacturing site with a pioneering mindset. /liliStrong verbal and written communication skills. /liliExcellent organizational skills, with the ability to prioritize tasks and manage multiple activities simultaneously to support smooth site operations, particularly during the project phase. /liliStrong problem-solving skills with the ability to quickly identify issues, think analytically, and develop pragmatic solutions to overcome challenges effectively. /liliFlexibility and adaptability, recognizing that priorities and responsibilities may change from one project phase to another. /liliFluent English communication skills, both written and spoken; German language skills are an advantage. /li /ulpbOur offer: /b /pulliA dynamic and rapidly growing work environment with internal development opportunities /liliEmployee development through numerous internal and external training opportunities /lili60% coverage of pension fund contributions by Bachem AG as well as option for extra‑mandatory pension provision with our Pension Plan Plus /liliAccess to the benefits platforms with discounts from external partners /liliFresh, healthy and varied food in our staff restaurant /liliA wide range of free sports activities on the Bachem Campus /li /ulpWould you like to shape global Operational Readiness frameworks with us? /ppLearn more about the Bachem Group and our working environment at the Stein site on our website. /ppAt bBachem /b, you’ll find a diverse, multicultural team. The b(a) /bin the job title stands for ball /b. We w