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compliance risk jobs near basel, bs

Senior Commissioning & Qualification Engineer Sisslerfeld (a), 100%

Bachem Holding AG -
Stein AG, AG

Jetzt bewerben

Details zur Stelle

Festanstellung | 100% | Pensum: 90-100%

Qualifikationen

Forschungserfahrung
Projektmanagement
Führungserfahrung
Kommunikationsfähigkeit

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.

The Bachem Group is investing in a new site in Sisslerfeld in Northwestern Switzerland. This step is part of the long-term strategy to expand production capacity by the end of the decade. The new production site will play a central role in achieving these goals.

The design phase of the project offers you unique opportunities to shape the future organization. We are looking for an experienced and dedicated Commissioning & Qualification (C&Q) Engineer (a), 100% to support our global capital projects and play a key role in the standardization and further development of C&Q processes across our international network. In this role, you will be responsible for the successful planning, execution, and management of C&Q activities – from concept to handover – and will contribute your expertise to a wide range of projects worldwide.

Your tasks:

Leadership of C&Q activities within multidisciplinary large capital projects
Coordination and management of C&Q‑related deviations and changes within defined timelines and in compliance with required quality standards
Responsibility for budget, schedule, prioritization, resources, and the quality of C&Q execution
Analysis of options, planning of execution strategies, and development of detailed C&Q schedules
Preparation of tender documents, support in procurement processes, and cost estimation
Ensuring a smooth handover to Operations and Quality
Risk management, including the derivation of proactive measures in case of deviations
Management and onboarding of the C&Q team, including external partners
Responsibility for training C&Q teams and ensuring adherence to internal standards
Clear, structured, and audience‑appropriate communication with all stakeholders
Close collaboration with global sites to harmonize C&Q standards and digital processes
Support in supplier evaluation and coaching of local SMEs
Active promotion of lean and agile methods within engineering and C&Q contexts
Further development of digital tools (e.g., Veeva), interfaces, and templates
Technical review activities in CAPEX projects
Participation in or leadership of international teams in GMP engineering, C&Q, and global initiatives

Your profile:

Completed degree in engineering, natural sciences, or a related field
At least 10 years of professional experience in the pharmaceutical or biopharmaceutical industry
Proven experience in international CAPEX projects (medium to large scale, complex requirements)
Extensive C&Q expertise in areas such as:

Biologics/Drug Substance, Drug Product
Small Molecules
Packaging, warehousing, GMP & non‑GMP infrastructure
Automation systems & new technologies

Strong knowledge of global regulations (FDA, EMA, ICH, ISPE Integrated Commissioning & Qualification, etc.)
Ideally experience with KNEAT Gx
Deep understanding of project management, PQS/EM compliance, and interfaces with Quality
Excellent communication, collaboration, and leadership skills
Analytical thinking and financial acumen to derive sustainable, efficient solutions
Willingness to drive change, creative thinking, and the ability to support organizations through transformation
Confident working style in global, culturally diverse teams

Our offer:

We offer you an exciting and challenging role in a dynamic and rapidly growing environment. This position provides you with the opportunity to make a lasting contribution to the company and the region.

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 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

compliance risk Jobs in basel, bs

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Ich möchte aktuelle Job-E-Mails für Stellen als compliance risk in basel, bs erhalten

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