- 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.
- 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
- Life Sciences - Engineering
- Aargau
- Contracting
- Vollzeit
- FAT/SAT, Validation, CSV
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Beschreibung
CQV Lead
m/f/d, Aargau
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:
Your background
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Larissa Birkle
Talent Acquisition Consultant
