In this role, the CQV Engineer will be responsible for fulfilling the requirements of the High Bay GMP Warehouse. This position involves leading the execution and coordination of the specified CQ activities within the warehouse, addressing both cold and ambient temperature conditions, and providing support for the building operations.

Project Duration: 12 Months 

Starting Date: ASAP

Place of Work: Stein (AG)

Responsibilities

  • Ensure CQV activities are conducted in line with relevant corporate standards and validation plans
  • Act as the subject matter expert for the High Bay warehouse scope, including cold and ambient environments
  • Support CQV execution for key equipment, such as semi-automated and fully automated visual inspection machines, and other small support equipment in Building 413 (e.g., LAF, thawing units, fridges, freezers)
  • Execute commissioning activities for assigned areas or systems
  • Coordinate execution activities with the CSV team and global IT teams
  • Lead CQV testing activities with support from vendors and contractors
  • Develop supporting validation plans related to the execution scope
  • Assist in updating the Master CQV Plan and related documents throughout the project lifecycle
  • Collaborate with other disciplines, including HSE, Automation, Electrical, Instrumentation, Operations, and Engineering
  • Support the C&Q Lead in the handover and release process

Candidate Profile

  • Relevant third-level or professional qualification
  • Minimum of 8 years of extensive experience in relevant areas/systems
  • Preferably a diploma in Mechanical or Chemical Engineering
  • Experience in authoring CQV lifecycle documents is essential
  • Ability to perform well under pressure and meet strict deadlines
  • Previous experience qualifying a High Bay warehouse (ambient and cold room) is required
  • Proactive and able to work independently
  • Field CQV execution experience is necessary
  • Significant experience with cGMP
  • Familiarity with Kneat for documentation development and execution
  • Strong interpersonal and communication skills
  • Fluent in English (C1 level); German is a plus

Job ID 41180323