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Senior Commissioning & Qualification (C&Q) Lead - Sisslerfeld CAPEX (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 newly planned site in Sisslerfeld, located in northwestern Switzerland. This step is part of its long-term strategy to expand production capacities by the end of the decade. The new production site will play a central role in achieving these objectives. The planning phase of the project offers you a unique opportunity to actively help shape the organization of the future.

 

To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our team in the Engineering department, we are looking for a dedicated Senior Commissioning & Qualification (C&Q) Lead – Sisslerfeld CAPEX (a), 100%

 

Your tasks:

  • Own the C&Q strategy, Master Plan and execution through OQ and transition to PQ/PPQ and Validation
  • Define the C&Q organization, governance and delivery model, including internal teams, partners, vendors and SMEs
  • Lead C&Q for process equipment, utilities, facilities, automation and computerized systems according to regulatory and Bachem requirements
  • Own the C&Q critical path, budget, resources, schedule, risks and performance, integrated with design, construction, system turnover and Operations readiness
  • Review and approve C&Q-relevant URS and design deliverables and define system boundaries, priorities, turnover sequences and C&Q packages
  • Ensure risk-based qualification and effective use of design reviews, FAT/SAT and commissioning evidence for qualification
  • Ensure compliant C&Q documentation, including risk assessments, traceability and IQ/OQ protocols and reports
  • Act as the primary C&Q interface to Quality Assurance, including qualification strategy, deviations, changes and release requirements
  • Ensure structured handover after OQ and maintain the C&Q interface with Operations/MPT, PQ/PPQ and Validation
  • Lead C&Q partners and suppliers, including selection, contracting, performance management and development/coaching of internal SMEs
  • Ensure safe commissioning, testing and start-up in close coordination with HSE
  • Drive standardization, digitalization, lean execution, best practices and global C&Q harmonization, including Kneat Gx and lessons learned
  • Support regulatory inspections, audits and project assurance reviews

 

Your profile:

  • Bachelor’s or master’s degree in engineering, natural/life sciences or a related discipline
  • 10+ years' pharmaceutical/biopharmaceutical experience, including C&Q leadership on large, complex GMP CAPEX projects
  • Proven leadership of multidisciplinary teams, partners and vendors, with accountability for budget, schedule, resources, risks and delivery
  • Strong expertise in integrated, system- and risk-based C&Q and pharmaceutical/biopharmaceutical API manufacturing
  • Strong technical experience with process equipment, facilities, utilities, automation and computerized systems
  • Strong knowledge of FDA, EMA, ICH, ISPE C&Q, ASTM E2500 and GAMP 5, and application of Bachem C&Q procedures and standards
  • Sound understanding of Pharmaceutical Quality Systems, data integrity, deviations, change control, QA and Validation interfaces
  • Experience with digital C&Q platforms, preferably Kneat Gx
  • Strong project, commercial and supplier-management capabilities and understanding of safe commissioning/start-up
  • Fluent in German and English
  • Strong leadership and communication skills with the ability to manage complex interfaces and make timely decisions
  • Pragmatic, delivery-focused and comfortable in a fast-track CAPEX environment

 

 

Our offer:

  • A dynamic and rapidly growing work environment with internal opportunities with internal development opportunities and continuing education
  • Additional days off (bridge days), which are determined each fall by Bachem
  • 60% coverage of pension fund contributions by Bachem, as well as option for extra-mandatory retirement savings through our optional Pension Plan Plus
  • Access to benefits platforms offering discounts from external partners
  • A wide range of free sports activities on the Bachem Campus

 

Would you like to drive innovation together with us?

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 at our location in Sisslerfeld!

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.

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