We are seeking a skilled and experienced CQV Lead Engineer to support the commissioning, qualification, and validation (CQV) activities for a High Bay GMP Warehouse. The role will involve both cold and ambient temperature environments and will include responsibility for driving and coordinating all CQ activities. The position is based at a client site in Stein, Switzerland, with an initial contract duration of 12 months.
Aufgaben
Key Responsibilities :
- Ensure CQV activities are carried out in compliance with internal guidelines, C&Q Plans, and supporting Validation Plans.
- Serve as the CQV Subject Matter Expert (SME) for the High Bay warehouse scope, including both cold and ambient temperature systems (high preference).
- Support CQV execution for key equipment, including semi-automated and fully automated visual inspection machines, as well as other small support equipment (e.g., LAF, thawing units, fridges, freezers, cold / freezer rooms) while aligning with the execution approach for equivalent systems in the QC building.
- Lead and execute commissioning activities for allocated areas or systems.
- Coordinate execution activities with the supporting CSV team and global IT teams.
- Lead C&Q testing activities, supported by vendors and contractors.
- Develop any supporting validation plans related to the scope of execution.
- Support the updates of the Master C&Q Plan and other supporting plans throughout the project lifecycle.
- Collaborate with various disciplines, including HSE, Automation, Electrical, Instrumentation, Operations, and Engineering.
Qualifikation
Qualifications :
Proven experience in CQV activities, particularly within GMP environments.Expertise in cold and ambient temperature systems.Strong background in commissioning and qualification of complex equipment and systems.Ability to work with cross-functional teams, including IT and CSV groups.Excellent communication and leadership skills.If you are interested in this challenging and rewarding opportunity, we would be pleased to receive your application.
NES Fircroft verfügt über mehr als 50 Jahre Erfahrung im Bereich des globalen Workforce-Management und der Rekrutierung von technischen Experten.