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

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

Senior Commissioning & Qualification Engineer

Key skills