Senior Commissioning & Qualification Engineer Sisslerfeld (a), 100%

Bachem Holding AG; Stein; Vor Ort; CHF 150.000 - 230.000; Vollzeit

Zusammenfassung

Bachem Holding AG is seeking an experienced Senior Commissioning & Qualification Engineer to lead C&Q efforts on global capital projects at the Sisslerfeld site in Northwestern Switzerland. You will steer C&Q activities from concept to handover, ensuring compliance and seamless integration with Operations and Quality across a global network.

The role requires a strong track record in pharmaceutical GMP projects, leadership capabilities, and robust knowledge of regulatory expectations (FDA, EMA,

Qualifikationen

• Completed degree in engineering or related field.
• 10+ years in pharma/biopharma industry.

Aufgaben

• Lead C&Q activities within large capital projects.
• Coordinate deviations and changes within timelines and quality standards.
• Manage budget, schedule, resources and quality of C&Q execution.
• Develop C&Q schedules and tender documents; support procurement.
• Ensure smooth handover to Operations and Quality.
• Collaborate with global sites to harmonize standards.

Kenntnisse

Leadership

C&Q management

Project management

GMP knowledge

Budget & schedule

Regulatory awareness

Stakeholder communication

Lean & agile methods

Supplier coordination

Team onboarding

Ausbildung

Engineering degree

Tools

KNEAT Gx

Jobbeschreibung

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Senior Commissioning & Qualification Engineer 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 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. We are looking for an experienced and dedicated Commissioning & Qualification (C&Q) Engineer (a), 100% to support our global capital projects and play a key role in the standardization and further development of C&Q processes across our international network. In this role, 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.

• 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
• 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 organizations through transformation
• Confident working style in global, culturally diverse teams

Our offer:

We offer you an exciting and challenging role in a dynamic and rapidly growing environment. This position provides you with the opportunity to make a lasting contribution to the company and the region.

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.