CQV Lead Engineer - GMP Warehouse (m/w/d)

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.

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.

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.