Senior Commissioning & Qualification Engineer

Responsibilities

• Lead C&Q activities within multidisciplinary large-scale capital projects from concept to handover
• Manage C&Q budgets, schedules, resource allocation, and execution quality
• Coordinate and manage C&Q-related deviations and changes in compliance with quality standards
• Develop detailed C&Q execution strategies, schedules, and tender documents
• Manage and onboard C&Q teams, including external partners and local SMEs
• Collaborate with global sites to harmonize C&Q standards and digital processes
• Drive the development of digital tools, templates, and interfaces (e.g., Veeva)
• Ensure smooth handover of qualified systems to Operations and Quality departments

Requirements

• 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 managing international CAPEX projects of medium to large scale
• Extensive C&Q expertise in biologics, small molecules, packaging, or GMP infrastructure
• Strong knowledge of global regulations including FDA, EMA, ICH, and ISPE standards
• Excellent leadership, communication, and project management skills
• Ability to work effectively within global, culturally diverse teams

Preferred Qualifications

• Experience with KNEAT Gx
• Experience with digital tools such as Veeva
• Proficiency in lean and agile engineering methodologies

Benefits

• Opportunity to play a key role in a major new production site development
• Challenging role in a dynamic, rapidly growing, and innovation-driven environment
• Ability to make a lasting contribution to the company's long-term global strategy

About the Company

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of expertise, Bachem provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide. The company operates internationally with headquarters in Switzerland and locations across Europe, the US, and Asia.