Process Validation Lead Engineer

vor 14 Stunden


Basel, Basel-Stadt, Schweiz NES Global Deutschland GmbH NES Fircroft Vollzeit
About the Role

We are seeking a seasoned Process Validation Lead Engineer to oversee commissioning, qualification, and validation (CQV) activities for our High Bay GMP Warehouse. This challenging opportunity involves managing both cold and ambient temperature environments.

Responsibilities
  • Ensure CQV activities align 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 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.
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 role offers a competitive salary range of €80,000 - €110,000 per annum, depending on qualifications and experience, plus benefits package, and opportunities for career growth and professional development.



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