Senior Commissioning & Qualification Engineer Sisslerfeld , 100%

more-jobs; Stein (AR); Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Bachem is expanding with a new site in Sisslerfeld, Northwestern Switzerland, seeking an experienced Commissioning & Qualification Engineer to lead C&Q activities on global capital projects. You will shape standards, manage from concept to handover, and drive lean, agile improvements across sites.

Ideal candidate has 10+ years in pharma/biopharma, strong GMP knowledge, and proven project leadership in international settings.

Qualifikationen

• Completed degree in engineering, natural sciences, or related field.
• At least 10 years of professional experience in pharmaceutical/biopharmaceutical industry.
• Proven experience in international CAPEX projects (medium to large scale).
• Extensive C&Q expertise in biologics/drug substance, drug product, packaging, GMP infra.

Aufgaben

• Lead C&Q activities within multidisciplinary large capital projects.
• Coordinate C&Q deviations and changes to meet timelines and quality.
• Manage budget, schedule, resources, and quality of C&Q execution.
• Develop detailed C&Q schedules and execution strategies.
• Prepare tender documents and assist in procurement; cost estimation.
• Ensure smooth handover to Operations and Quality; risk management.
• Lead and onboard C&Q team and external partners.
• Train C&Q teams and ensure adherence to standards.
• Communicate clearly with all stakeholders; collaborate globally.
• Support supplier evaluation and coaching of local SMEs.

Kenntnisse

Leadership

Project management

Communication

Team leadership

GMP expertise

Ausbildung

Engineering degree

Tools

KNEAT Gx

Jobbeschreibung

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

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 . The company is listed on the SIX Swiss Exchange. For further information, see .

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

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 designphase 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?