Senior Commissioning & Qualification (C&Q) Lead (f/m/d), 100%

Bachem AG est a la recherche d'un(e) Senior Commissioning & Qualification (C&Q) Lead (f/m/d), 100% pour son site de Bubendorf.

Bachem AG recrute un Senior C&Q Lead (f/m/d) pour son équipe. C’est une chance de contribuer à un environnement innovant.
Tâches
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Diriger les activités de validation et de qualification dans les installations.
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Développer des stratégies C&Q et des plans de qualification basés sur les risques.
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Assurer la conformité aux normes GMP et gérer les parties prenantes.
Compétences
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Diplôme en ingénierie ou sciences de la vie avec expérience en C&Q.
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Excellente connaissance des réglementations GMP et des méthodologies de qualification.
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Compétences en gestion de projets et communication en allemand et anglais.
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
.
Senior Commissioning & Qualification (C&Q) Lead (f/m/d), 100%
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:
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Lead and manage commissioning, qualification, and validation activities for pharmaceutical facilities, utilities, equipment, automation, and computerized systems
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Develop and implement C&Q strategies, C&Q Master Plans, and risk‑based qualification approaches
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Author, review, and approve GMP documentation including URS, risk assessments, IQ/OQ/PQ protocols and reports
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Ensure compliance with GMP regulations and internal quality standards
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Act as the primary C&Q interface to Quality Assurance and support regulatory inspections and audits
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Coordinate cross‑functional stakeholders and manage external vendors and CQV consultants
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Monitor progress, manage risks, deviations, and change controls, and provide transparent reporting to project leadership
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Drive standardization, continuous improvement, and best practices across C&Q activities
Your profile:
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Bachelor's or Master's degree in Engineering, Life Sciences, or a related technical discipline
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Extensive experience in Commissioning & Qualification / Validation within the pharmaceutical industry
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Proven track record of leading C&Q activities on large scale GMP capital projects
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Strong knowledge of GMP regulations (EU/FDA), ISPE guidelines, and risk based qualification methodologies
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Parcours professionnel with facilities and utilities (e.g. HVAC, media systems); automation and CSV expertise is an advantage
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Excellent written and spoken German and English
Our offer:
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A dynamic and rapidly growing work environment with internal development and training opportunities
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Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction
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Company‑run daycare center on the Bachem Campus in Bubendorf
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60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus
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Access to benefits platforms with discounts from external partners
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Fresh, healthy and varied food in our staff restaurant
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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!

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