About this role
Job title: Senior Commissioning & Qualification (C&Q) Lead
About the Role Senior Commissioning & Qualification (C&Q) Lead will be responsible for strategic planning, execution, and oversight of commissioning, qualification, and validation activities for GMP-regulated pharmaceutical facilities. You will ensure that all systems, equipment, and utilities are delivered in full compliance with regulatory requirements, quality standards, and project timelines. Acting as a technical and regulatory leader, you will interface closely with Engineering, Quality, Automation, Operations, and external partners throughout the project lifecycle.
What You'll Do
- 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.
What We're Looking For
- 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.
Nice to Have
- Automation and Computerized System Validation (CSV) experience.
Compensation & Benefits
- Dynamic and rapidly growing work environment with internal development and training opportunities.
- Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction.
- Company-run daycare center on the Bachem Campus in Bubendorf.
- 60% coverage of pension fund contributions by Bachem AG and option for extra-mandatory pension provision with our Pension Plan Plus.
- Access to benefits platforms with discounts from external partners.
- Fresh, healthy and varied food in staff restaurant.
- A wide range of free sports activities on the Bachem Campus.