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

Bachem Holding AG; Stein; On-site; EUR 161,000 - 204,000; Full time

Benefits offered by this job

Career development

Pension benefits: 60%

Staff restaurant

Discount platform

Sports activities

Comprehensive training opportunities

Job summary

Bachem Holding AG is seeking a Quality Engineering Manager CSV to lead qualification and validation of computerized systems for our new Sisslerfeld site. You will drive CSV activities from design through operational phases, ensuring GMP compliance and inspection readiness.

Ideal candidates have 3+ years in pharma CSV within CAPEX projects, strong regulatory knowledge, and hands-on experience with PCS7/MES, LIMS and QA processes. English fluency is required; German is advantageous.

Qualifications

• University/Applied Sciences degree in Engineering, Chemistry, Pharmacy or related discipline.
• Min. 3 years in pharma CAPEX projects with CSV systems (PCS7/MES, MOS, LIMS).
• Qualification and validation for API process systems.
• Regulatory knowledge on qualification/validation of computerized systems, lab instruments, process systems, water systems, cleanrooms, cleaning and process validation.
• Experience with electronic validation systems like KNEAT Gx is a plus.
• Strong ownership, communication and organizational skills.
• English fluency; German a plus.

Responsibilities

• Ensure GMP compliance across the project lifecycle.
• Review and approve qualification and validation documentation (QMP, URS, SIA, QRA).
• Provide quality oversight for commissioning/qualification of computerized systems; validate PCS7/MES, LIMS, IT systems (DQ/IQ/OQ/PQ).
• Support design, qualification readiness, and regulatory compliance of computerized systems.
• Conduct design reviews; manage deviations, change controls, and system releases from a quality perspective.
• Support supplier qualification and cross-functional collaboration for milestone delivery.
• Maintain GMP compliance with quality oversight during operation and periodic reviews.
• Support audits and inspections; drive QMS effectiveness and continuous improvement.

Skills

CSV knowledge

C&Q experience

GMP compliance

Regulatory knowledge

Quality oversight

Communication skills

Project coordination

English proficiency

Education

Bachelor's degree in Engineering/Chemistry/Pharmacy

Tools

PCS7/MES

LIMS

KNEAT Gx

MOS

Job description

Quality Engineering (QE) Manager CSV - 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 designphase 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.

• 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.).
• 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 project phase.
• 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.

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?

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.

Please note: unsolicited resumes from recruitment agencies will not be considered.