CQV Lead

Main responsibilities:

• Ensure that CQV activities are executed, the C&Q Plan and supporting Validation Plans.
  
• C&Q SME warehouse scope - cold and ambient.
  
• Support C&Q execution for key euipment (Semiautomated and fully automated visual inspection machine), other small support equipment (thawing units, fridges, freezers, cold /freezer rooms)
  
• Coordination of execution activities with supporting CSV Team and global IT teams.
  
• Lead C&Q testing activities supported by external vendors and/or contractors.
  
• Develop any supporting validation plans related to scope of execution.
  
• Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
  
• Interface and with other disciplines: HSE, Automation, Electrical, Instrumentation, Operation and Engineering
  
• Generate, review, approve, CQV test scripts in accordance with verification plans and any applicable site commissioning or validation plans or procedures.
  
• Lead the management of change for his area elements and ensures that the change is controlled, communicated and implemented in the most cost effective and timely manner
  
• Ensure C&Q execution milestones are completed as per baseline schedule
  
• C&Q field execution completed in a safely manner and following Lonza HSE standards. This will include preparation of Lock-Out-Tag-Out, PSHR completion, Method Statements.
  
• Support the C&Q execution team as Kneat Super User.
  

Your background

• Minimum of 8 Years extensive experience in areas/systems under future responsibility.
  
• Preferably Diploma level degree in Mechanical or Chemical Engineering.
  
• Previous experience in authoring CQV lifecycle documents necessary
  
• Previous experience in qualifying warehouse (ambient and 2 to 8 degree cold room) necessary
  
• Field CQV execution experience.
  
• Considerable experience with cGMP
  
• Experience in use of Kneat for documentation development and execution