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

Bachem; Stein; Vor Ort; CHF 150.000 - 210.000; Vollzeit

Zusammenfassung

The Bachem Group is expanding with a new site in Sisslerfeld, Northwestern Switzerland. We seek a seasoned Commissioning & Qualification (C&Q) Engineer to lead C&Q activities across global capital projects from concept to handover.

You will standardize C&Q processes, manage budgets and schedules, and mentor internal and external teams, promoting lean and agile methods while ensuring GMP compliance and alignment with global sites.

Qualifikationen

• Minimum 10 years of professional experience in pharma/biopharma
• International CAPEX project experience (medium to large scale)
• Extensive C&Q expertise in biologics, Drug Substance/Product, packaging, GMP & non-GMP infrastructure
• Strong knowledge of global regulations (FDA, EMA, ICH, ISPE) and PQS/EM compliance
• Proven leadership, stakeholder management, and ability to drive change

Aufgaben

• Lead C&Q activities within multidisciplinary large capital projects
• Coordinate C&Q deviations and changes within defined timelines and quality standards
• Manage budget, schedule, prioritization, resources, and quality of C&Q execution
• Analyze options, plan execution strategies, and develop detailed C&Q schedules
• Prepare tender documents and support procurement processes
• Ensure smooth handover to Operations and Quality
• Promote lean and agile methods within engineering and C&Q contexts
• Collaborate with global sites to harmonize C&Q standards and digital processes
• Lead international teams in GMP engineering and C&Q initiatives

Kenntnisse

C&Q expertise

CAPEX projects

Leadership

Project management

Communication

Regulatory knowledge

GMP knowledge

Lean & agile

Financial acumen

Ausbildung

Engineering degree

Natural sciences degree

Tools

KNEAT Gx

Jobbeschreibung

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
• 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!