Senior Commissioning&Qualification Engineer Sisslerfeld …, Stein

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience, 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.

Senior Commissioning&Qualification Engineer (f/m/d), 100%

This role supports our global capital projects and plays a key role in standardising and developing C&Q processes across our international network. You will be responsible for the successful planning, execution, and management of C&Q activities– from concept to handover – and will contribute your expertise to a wide range of projects worldwide.

Responsibilities

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, prioritisation, 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 harmonise 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

Your profile

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: 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 organisations through transformation

Confident working style in global, culturally diverse teams

Our offer We offer a challenging role in a dynamic, rapidly growing environment. This position provides opportunity to make a lasting contribution to the company and the region.

We look forward to receiving your complete application documents via our application portal.

Learn more about the Bachem Group and get inspired by our exciting work environment!

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

#J-18808-Ljbffr