Senior Commissioning & Qualification Lead

Lead and manage commissioning, qualification, and validation activities for pharmaceutical facilities, utilities, equipment, automation, and computerized systems. Develop and implement C&Q; strategies, C&Q; Master Plans, and risk‑based qualification approaches. Author, review, and approve GMP documentation including URS, risk assessments, IQ/OQ/PQ protocols and reports. Ensure compliance with GMP regulations and internal quality standards. Act as the primary C&Q; interface to Quality Assurance and support regulatory inspections and audits. Coordinate cross‑functional stakeholders and manage external vendors and CQV consultants. Monitor progress, manage risks, deviations, and change controls, and provide transparent reporting to project leadership. Drive standardization, continuous improvement, and best practices across C&Q; activities.

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.

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical discipline

• Extensive experience in Commissioning & Qualification / Validation within the pharmaceutical industry

• Proven track record of leading C&Q; activities on large scale GMP capital projects

• Strong knowledge of GMP regulations (EU/FDA), ISPE guidelines, and risk based qualification methodologies

• Experience with facilities and utilities (e.g. HVAC, media systems); automation and CSV experience is an advantage

• Excellent written and spoken German and English