careers.bachem.com
Quality Engineering (QE) Manager CSV - Sisslerfeld (a) 100%
- Compensation
- Not disclosed
- Location
- Not listed
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- Not specified
- Category
- Not specified
- Posted
Skills
Must have
- University degree or degree from a University of Applied Sciences in Engineering, Chemistry, Pharmacy, or a related discipline.
- Strong knowledge of Commissioning & Qualification (C&Q) and Computerized System Validation (CSV), including a minimum of three years of experience in pharmaceutical CAPEX projects involving CSV system
- Qualification and validation expertise for process systems used in API manufacturing.
- Thorough knowledge of regulatory requirements related to the qualification and validation of computerized systems, laboratory instruments, process systems, purified water systems, cleanrooms, as well
- Experience with electronic validation systems such as KNEAT Gx is considered an advantage.
- High level of commitment and a 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 and effective communication skills.
- Excellent organizational skills, with the ability to prioritize tasks and manage multiple activities simultaneously. This is critical to supporting smooth site operations, particularly during the proj
- Strong problem-solving skills, with the ability to quickly identify issues, think analytically, and develop pragmatic solutions to effectively address challenges.
- Flexibility and adaptability, recognizing that priorities and responsibilities may change throughout the different project phases.
- Excellent written and spoken English skills; German language skills are an advantage.
Full description
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 CSV (a) 100%. 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.
Your tasks
- Ensure GMP compliance and implementation of applicable pharmaceutical regulations throughout the project lifecycle.
- Review and approve qualification and validation documentation, including Qualification Master Plans, URS, System Impact Assessments, and Quality Risk Assessments.
- Provide Quality oversight for Commissioning & Qualification of computerized systems, Validation of computerized equipment and IT systems including DQ, IQ, OQ, and PQ.
- Support the design, qualification readiness, and compliance of computerized systems such as PCS7/MES, Monitoring System, and LIMS etc.
- Conduct design reviews and manage deviations, change controls, and system release activities from a quality perspective.
- Support supplier qualification and collaborate with internal and external stakeholders to ensure successful project execution and milestone delivery.
- Ensure ongoing GMP compliance through quality oversight of computerized systems, quality documentation, deviations, change controls, and periodic review activities during operational phase.
- Support audits and regulatory inspections while driving QMS effectiveness and continuous improvement in collaboration with cross-functional stakeholders.
Your profile
- University degree or degree from a University of Applied Sciences in Engineering, Chemistry, Pharmacy, or a related discipline.
- Strong knowledge of Commissioning & Qualification (C&Q) 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.
- Qualification and validation expertise for process systems used in API manufacturing.
- Thorough 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.).