Quality Engineering (QE) Manager CSV - Sisslerfeld (a) 100%

h3Quality Engineering (QE) Manager CSV - 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 CSV (a) 100%. /b In this key role, you will ensure compliance and quality oversight for computerized systems throughout their lifecycle, driving CSV, qualification, and validation activities from design and implementation through commercial operations, while enabling regulatory compliance, inspection readiness, and operational excellence. /ppbYour tasks /b /pulliEnsure GMP compliance and implementation of applicable pharmaceutical regulations throughout the project lifecycle. /liliReview and approve qualification and validation documentation, including Qualification Master Plans, URS, System Impact Assessments, and Quality Risk Assessments. /liliProvide Quality oversight for Commissioning Qualification of computerized systems, Validation of computerized equipment and IT systems including DQ, IQ, OQ, and PQ. /liliSupport the design, qualification readiness, and compliance of computerized systems such as PCS7/MES, Monitoring System, and LIMS etc. /liliConduct design reviews and manage deviations, change controls, and system release activities from a quality perspective. /liliSupport supplier qualification and collaborate with internal and external stakeholders to ensure successful project execution and milestone delivery. /liliEnsure ongoing GMP compliance through quality oversight of computerized systems, quality documentation, deviations, change controls, and periodic review activities during operational phase. /liliSupport audits and regulatory inspections while driving QMS effectiveness and continuous improvement in collaboration with cross-functional stakeholders. /li /ulpbYour profile /b /pulliUniversity degree or degree from a University of Applied Sciences in Engineering, Chemistry, Pharmacy, or a related discipline. /liliStrong knowledge of Commissioning Qualification (CQ) and Computerized System Validation (CSV), including a minimum of three years of experience in pharmaceutical CAPEX projects involving CSV systems such as PCS7/MES, MOS, and LIMS. /liliQualification and validation expertise for process systems used in API manufacturing. /liliThorough knowledge of regulatory requirements related to the qualification and validation of computerized systems, laboratory instruments, process systems, purified water systems, cleanrooms, as well as cleaning and process validation requirements (e.g., ASTM E2500, EU GMP Guidelines, Annexes 1, 11 and 15, PIC/S Guidelines, ICH requirements, FDA regulations, etc.). /liliExperience with electronic validation systems such as KNEAT Gx is considered an advantage. /liliHigh level of commitment and a 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 and effective communication skills. /liliExcellent organizational skills, with the ability to prioritize tasks and manage multiple activities simultaneously. This is critical to supporting 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 effectively address challenges. /liliFlexibility and adaptability, recognizing that priorities and responsibilities may change throughout the different project phases. /liliExcellent written and spoken English skills; German language skills are an advantage. /li /ulpbOur offer: /b /pulli* /li /ululliA 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? /ppAt 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. /ppPlease note: unsolicited resumes from recruitment agencies will not be considered. /ppbShare this job posting by email /b /p #J-18808-Ljbffr