CQV Lead, Stein

vor 1 Tag

Stein AR, Schweiz TN Switzerland Vollzeit

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Proclinical is seeking a Lead Engineer to join our partner's team on a contract basis. This role focuses on overseeing (CQV) activities for a High Bay Good Manufacturing Practice Warehouse, catering to both cold and ambient storage needs. We are looking for a proactive individual who thrives in a dynamic environment and is passionate about contributing to the Life Science industry.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

  • Drive execution and coordination of CQV activities in the warehouse.
  • Ensure compliance with internal guidelines, C&Q Plan, and Validation Plans.
  • Act as C&Q Subject Matter Expert for the High Bay warehouse scope.
  • Support C&Q execution for key equipment, including visual inspection machines and cold storage units.
  • Execute commissioning activities for designated areas or systems.
  • Coordinate with CSV and global IT teams for execution activities.
  • Lead C&Q testing activities with vendors and contractors.
  • Update Master C&Q Plan and supporting plans throughout the project lifecycle.
  • Collaborate with other disciplines such as HSE, Automation, and Engineering.
  • Assist with the Handover and Release process.

Key Skills and Requirements:

  • Degree in Mechanical Engineering, Chemical Engineering, or related field.
  • Experience in CQV lifecycle document authoring and execution.
  • Experience in qualifying High Bay warehouses with cold storage.
  • Field CQV execution experience and familiarity with cGMP.
  • Strong interpersonal and communication skills.
  • Fluent in English; German is an advantage.
  • Experience with Kneat for documentation development and execution.
  • Ability to work under pressure and meet strict deadlines.
  • Proactive and able to work independently.
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