18 beste Stellen als director, qms bpo, quality issue escalation, risk & knowledge in basel, bs – aktuell auf Personalsuche

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Medical Device Platform Design Engineer
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director, qms bpo, quality issue escalation, risk & knowledge jobs near basel, bs

Senior Commissioning Manager Sisslerfeld (a), 100%

Bachem Holding AG -
Stein AG, AG

Jetzt bewerben

Details zur Stelle

Festanstellung | 100% | Pensum: 90-100%

Qualifikationen

Englisch
Forschungserfahrung
Kommunikationsfähigkeit
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.

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 Commissioning Manager (a), 100% to lead and coordinate the commissioning phase (C&Q) of major pharmaceutical CAPEX projects on the client side. In this role, you will be responsible for planning, managing, and ensuring the quality of all commissioning activities from the concept phase through final handover, ensuring that all work is carried out in a GMP‑compliant, safe, and efficient manner.

Your tasks:

Development, structuring, and further enhancement of commissioning concepts, strategies, and execution models (including lean‑based workflows)
Management of the complete commissioning process (pre‑commissioning, cold/hot commissioning, testing, start‑up)
Leadership and coordination of internal and external commissioning teams
Planning and monitoring of schedules, costs, quality, and risks
Close collaboration with the program’s Qualification Manager
Interdisciplinary coordination with Engineering, Automation, Quality, Operations, HSE, suppliers, and construction management
Ensuring a structured flow of information among all project stakeholders
Ensuring all safety‑related requirements during commissioning (HSE, HAZOP, permits, work authorizations)
Conducting or supporting risk analyses and hazard assessments in line with current industry role expectations (e.g., hazard assessments & HSE implementation as core commissioning tasks)
Proactive enforcement of safety standards, including intervention in critical situations
Ensuring GMP/GDP and GAMP compliance of commissioning activities, considering an integrated commissioning and qualification approach
Development, review, and approval of test plans, logs, checklists, and technical documents
Support of qualification activities (IQ/OQ/PQ)
Contribution to the development and standardization of internal company guidelines for commissioning
Evaluation of new tools, methods, and processes to improve efficiency, quality, and safety
Application of lean principles to optimize workflows and resource utilization

Your profile:

Degree in engineering (process engineering, mechanical engineering, electrical engineering, pharmaceutical engineering, or similar)
Several years of professional experience in commissioning / C&Q, ideally in large‑scale pharma or biotech projects
Strong knowledge of GMP regulations, technical standards, and plant commissioning
Experience in leading and coordinating interdisciplinary teams
Solid understanding of HSE requirements, risk analyses, and safety‑related processes
Knowledge of lean methods (e.g., pull planning, visual management, takt planning)
Excellent German and English skills
Strong communication skills, assertiveness, and high problem‑solving competence

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.

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Ich möchte aktuelle Job-E-Mails für Stellen als director, qms bpo, quality issue escalation, risk & knowledge in basel, bs erhalten

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