Senior C&Q Engineer for Global GMP Projects

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 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.