We are currently seeking a highly skilled and motivated GMP High Bay Warehouse Specialist to join our client's team in Stein.
The Specialist will be driving the execution and coordination of the defined CQV activities in the warehouse for both cold and ambient temperatures and support building.
Responsibilities:
- Ensure that CQV activities are executed in accordance with CORP 35, the C&Q Plan and supporting Validation Plans
- C&Q SME for High Bay warehouse scope - cold and ambient (high preference).
- Support C&Q execution for key main equipment: Semi-automated and fully automated visual inspection machine), other small support equipment (LAF, thawing units, fridges, freezers, cold /freezer rooms, etc.), including alignment with execution approach of equivalent systems in QC building.
- Execution of the commissioning activities related to allocated areas or systems.
- Coordination of execution activities with supporting CSV Team and global IT teams.
- Lead C&Q testing activities supported by vendors and contractors
- Develop any supporting validation plans related to scope of execution.
- Support the updates of Master C&Q Plan and supporting plans during project execution life cycle.
- Interface and with other disciplines: HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.
- Assist the C&Q Lead with the Handover and Release process.
Your Profile:
- Ability to work well under pressure and within strict deadlines
- Minimum of 8 Years extensive experience in areas/systems under future responsibility.
- Diploma level degree in Mechanical or Chemical Engineering.
- Previous experience in authoring CQV life cycle documents necessary
- Previous experience in qualifying a High bay warehouse (ambient and 2 to 8 degree cold room) necessary
- Field CQV execution experience.
- Considerable experience with cGMP
- Experience in use of Kneat for documentation development and execution
For further information about this position, please apply with your CV
*Please note, only those with the right to work in Switzerland or EU passport holders can apply!*
