CQV Lead Engineer – GMP Warehouse

vor 14 Stunden

Basel, Schweiz CTC Resourcing Solutions Vollzeit

The Life Science Career Network– CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services.

For our client, a leading Swiss CRO/CMO company, we are looking for a CQV Lead Engineer Warehouse (6245) in the Basel area for initially 1 year.

The CQV Lead Engineer will drive the execution and coordination of the defined CQ activities in the warehouse for both cold and ambient temperatures and support building.

Responsibilities:

  1. Ensure that CQV activities are executed in accordance with internal guidelines, the C&Q Plan and supporting Validation Plans.
  2. C&Q SME for High Bay warehouse scope – cold and ambient (high preference).
  3. Support C&Q execution for key main equipment: Semiautomated and fully automated visual inspection machine, other small support equipment on site such as LAF, thawing units, fridges, freezers, cold/freezer rooms, etc. including alignment with execution approach of equivalent systems in QC building.
  4. Execution of the commissioning activities related to allocated areas or systems.
  5. Coordination of execution activities with supporting CSV Team and global IT teams.
  6. Lead C&Q testing activities supported by vendors and contractors.
  7. Develop any supporting validation plans related to scope of execution.
  8. Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
  9. Interface with other disciplines: HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.
  10. Assist the C&Q Lead with the Handover and Release process.

Candidate Profile:

  1. Bachelor's or Master's degree in Mechanical or Chemical Engineering, or related discipline.
  2. Min 8 years experience in areas/systems under future responsibility.
  3. Previous experience in authoring CQV lifecycle documents necessary.
  4. Previous experience in qualifying a High bay warehouse (ambient and 2 to 8 degree cold room) necessary.
  5. Field CQV execution experience.
  6. Considerable experience with cGMP.
  7. Strong interpersonal and communication skills.
  8. Fluent English (C1 Level), German an advantage.
  9. Experience in use of Kneat for documentation development and execution.
  10. Ability to work well under pressure and within strict deadlines.
  11. Proactive and working independently.

Interested? Contact us

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