CQV Lead

Do you have a strong experience in qualification and validation of equipment and in a pharmaceutical manufacturing environment?

Our client in Stein needs your support and offers exciting projects and responsibilities.

Duration: end of 2024

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

Sounds like a great job?
Then we look forward to receiving your complete application documents through our online application form.

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Find more vacancies at:

• Life Sciences - Engineering
• Aargau
• Contracting
• Vollzeit
• FAT/SAT, Validation, CSV

Larissa Birkle
Talent Acquisition Consultant