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Senior Commissioning & Qualification (C&Q) Lead (a), 100%

Bachem Holding AG -
Bubendorf, BL

Jetzt bewerben

Details zur Stelle

Festanstellung | 100% | Pensum: 90-100%
vor 9 Tagen

Leistungen

Zusätzliche Urlaubstage
Pensionskasse

Qualifikationen

Englisch
Forschungserfahrung
Master
Bachelor
HLK
Deutsch

Vollständige Stellenbeschreibung

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.

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

In this role, you are responsible for the strategic planning, execution, and oversight of commissioning, qualification, and validation activities for GMP‑regulated pharmaceutical facilities. Furthermore, this role ensures 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, the position interfaces closely with Engineering, Quality, Automation, Operations, and external partners throughout the project lifecycle.

Your tasks:

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

Your profile:

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

Our offer:

A 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 as well as 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 our staff restaurant
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 Bubendorf!

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.

Jetzt bewerben

Erweiterte Suche

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Senior Commissioning & Qualification (C&Q) Lead (a), 100%

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