C&Q Lead

We are seeking a C&Q Lead to provide technical and leadership support for the commissioning and qualification of sterile drug product manufacturing systems. This position plays a pivotal role in ensuring compliant and timely qualification of equipment and facilities. You will coordinate multidisciplinary teams and external partners to deliver validated, inspection-ready systems in alignment with GMP and engineering standards.Key ResponsibilitiesLead the planning, coordination, and execution of commissioning and qualification activities for process and utility systems.Develop, review, and approve C&Q documentation (URS, FAT, SAT, IQ, OQ, PQ).Define C&Q strategy, schedule, and resource plan for assigned areas.Supervise internal and external C&Q engineers during execution and ensure adherence to safety and quality standards.Manage deviations, change controls, and CAPAs linked to C&Q activities.Interface with Project Management, QA, Validation, and Operations to ensure seamless handover to manufacturing.Present qualification approach and results during audits and regulatory inspections.Contribute to the continuous improvement of C&Q templates, workflows, and best practices.RequirementsBachelor’s or Master’s degree in Mechanical, Chemical, Electrical, or Process Engineering.8+ years of relevant experience in commissioning and qualification within GMP-regulated sterile/aseptic facilities.Strong understanding of GMP, GEP, Annex 1, ISPE Baseline Guides, and ASTM E2500 principles.Demonstrated leadership of C&Q or CQV teams within capital or retrofit projects.Fluent in English; German a benefit.