Senior Validation Specialist

vor 1 Monat


Basel, Basel-Stadt, Schweiz NES Global Deutschland GmbH NES Fircroft Vollzeit
Job Description

We are seeking a highly skilled and experienced Senior Validation Specialist to support the commissioning, qualification, and validation activities for a High Bay GMP Warehouse. The role involves working in both cold and ambient temperature environments and requires driving and coordinating all CQV activities.

The position is based at a client site in Stein, Switzerland, with an initial contract duration of 12 months.

Main 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.
  • Support CQV execution for key equipment, including semi-automated and fully automated visual inspection machines, as well as other small support equipment.
  • 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.
Requirements
  • 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.
Benefits

This challenging and rewarding opportunity offers a competitive salary range of €80,000 - €110,000 per annum, depending on experience and qualifications.



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