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

h3Quality Engineering (QE) Manager Facility Utility Systems - Sisslerfeld (a) 100% # /h3 pBachem 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 /p pThe 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. /p pAs part of the development of our new Sisslerfeld manufacturing site, we are looking for a bQE Manager Facility Utility Systems. /b 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. /p pbYour tasks /b /p ul liEnsure GMP compliance and implementation of regulatory requirements throughout all project phases from design until operational phase. /li liProvide Quality Engineering oversight for facility, utility, HVAC systems, Cleanrooms, Clean Utilities, Media and Process Gases as well as for computerized systems. /li liReview and approve qualification, validation, and quality risk management documentation. /li liSupport Commissioning and Qualification (DQ, IQ, OQ, PQ), process validation, and cleaning validation activities. /li liEnsure qualification readiness and compliance of critical facility and utility systems, including computerized systems. /li liManage quality-related deviations, change controls, and QMS improvement activities. /li liSupport regulatory inspections and customer audits during operational phase, ensuring continuous inspection readiness. /li liDrive compliance, quality performance, and continuous improvement in collaboration with cross-functional stakeholders. /li /ul pbYour profile /b /p ul liUniversity degree or University of Applied Sciences degree in Engineering, Chemistry, Pharmacy, or a related scientific discipline. /li liStrong 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. /li liQualification and validation expertise for process systems used in API manufacturing. /li liThorough 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. /li liKnowledge of electronic validation systems such as KNEAT Gx is considered an advantage. /li liHigh level of commitment and strong sense of ownership for both the project and the organization. /li liEnthusiasm for building and establishing a new GMP manufacturing site with a pioneering mindset. /li liStrong verbal and written communication skills. /li liExcellent organizational skills, with the ability to prioritize tasks and manage multiple activities simultaneously to support smooth site operations, particularly during the project phase. /li liStrong problem-solving skills with the ability to quickly identify issues, think analytically, and develop pragmatic solutions to overcome challenges effectively. /li liFlexibility and adaptability, recognizing that priorities and responsibilities may change from one project phase to another. /li liFluent English communication skills, both written and spoken; German language skills are an advantage. /li /ul pbOur offer: /b /p ul liA dynamic and rapidly growing work environment with internal development opportunities /li liEmployee development through numerous internal and external training opportunities /li li60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus /li liAccess to the benefits platforms with discounts from external partners /li liFresh, healthy and varied food in our staff restaurant /li liA wide range of free sports activities on the Bachem Campus /li /ul pAt bBachem /b, you-ll find a diverse, multicultural team. The b(a) /bin the job title stands for ball /b. We welcome applications from all candidates. What matters are your skills and motivation-regardless of age, gender, background, religion, or sexual orientation. /p pPlease note: unsolicited resumes from recruitment agencies will not be considered. /p #J-18808-Ljbffr