Senior Commissioning & Qualification Engineer

Leadership of C&Q; activities within multidisciplinary large capital projects Coordination and management of C&Q;‑related deviations and changes within defined timelines and in compliance with required quality standards Responsibility for budget, schedule, prioritization, resources, and the quality of C&Q; execution Analysis of options, planning of execution strategies, and development of detailed C&Q; schedules Preparation of tender documents, support in procurement processes, and cost estimation Ensuring a smooth handover to Operations and Quality Risk management, including the derivation of proactive measures in case of deviations Management and onboarding of the C&Q; team, including external partners Responsibility for training C&Q; teams and ensuring adherence to internal standards Clear, structured, and audience‑appropriate communication with all stakeholders Close collaboration with global sites to harmonize C&Q; standards and digital processes Support in supplier evaluation and coaching of local SMEs Active promotion of lean and agile methods within engineering and C&Q; contexts Further development of digital tools (e.g., Veeva), interfaces, and templates Technical review activities in CAPEX projects Participation in or leadership of international teams in GMP engineering, C&Q;, and global initiatives

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. The Bachem Group is investing in a new 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.

• Completed degree in engineering, natural sciences, or a related field

• At least 10 years of professional experience in the pharmaceutical or biopharmaceutical industry

• Proven experience in international CAPEX projects (medium to large scale, complex requirements)

• Extensive C&Q; expertise in areas such as: Biologics/Drug Substance, Drug Product; Small Molecules; Packaging, warehousing, GMP & non‑GMP infrastructure; Automation systems & new technologies

• Strong knowledge of global regulations (FDA, EMA, ICH, ISPE Integrated Commissioning & Qualification, etc.)

• Ideally experience with KNEAT Gx

• Deep understanding of project management, PQS/EM compliance, and interfaces with Quality

• Excellent communication, collaboration, and leadership skills

• Analytical thinking and financial acumen to derive sustainable, efficient solutions

• Willingness to drive change, creative thinking, and the ability to support organizations through transformation

• Confident working style in global, culturally diverse teams