The posting
Quality Engineering (QE) Manager Downstream - Sisslerfeld (a) 100% #
Bachem 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 www.bachem.com.
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 Downstream (a) 100%. In this key role, you will provide Quality oversight by partnering with cross-functional teams to deliver compliant, robust, and inspection-ready manufacturing systems that support operational excellence and regulatory compliance from startup through commercial manufacturing.
Your tasks
- Ensure GMP compliance and implementation of applicable pharmaceutical regulations throughout the project lifecycle.
- Review and approve qualification, validation, and quality risk management documentation, including Qualification Master Plans, URS, System Impact Assessments, and Quality Risk Assessments.
- Provide Quality Engineering oversight for C&Q including DQ, IQ, OQ, and PQ, cleaning and process validation activities.
- Support the design, qualification readiness, and compliance of manufacturing systems, including buffer preparation and storage, chromatography, depth filtration and freeze drying.
- Conduct design reviews and manage deviations, change controls, and system release activities from a quality and compliance perspective.
- Oversee qualification, calibration, and maintenance activities for equipment, facilities, laboratory instruments, computerized systems, and analytical methods.
- Ensure ongoing GMP compliance through quality oversight of manufacturing operations, quality documentation, deviations, change controls, and periodic review activities during the Operational Phase.
- Support audits and regulatory inspections while driving QMS effectiveness, continuous improvement, and cross-functional collaboration.
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 Computer System Validation (CSV), including a minimum of three years of experience in pharmaceutical CAPEX projects related to downstream processing, including media preparation, chromatography, ultrafiltration and freeze drying.
- Qualification and validation expertise for process systems used in API manufacturing.
- Thorough knowledge of regulatory requirements related to 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).
- Experience with 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 and effective 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 throughout different project phases.
- Excellent written and spoken English skills; German 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 Stein site on our website.
At Bachem, you-ll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation-regardless of age, gender, background, religion, or sexual orientation.
