Lead CQV Consultant

vor 2 Monaten

Bern, Schweiz Consultys Vollzeit

Missions
As part of the C&Q team reporting to the C&Q Manager, the main responsibilities and tasks include but are not limited to:

  1. Ensure that CQV activities are executed in accordance with the C&Q Plan and supporting Validation Plans.
  2. Lead and coordinate the C&Q execution effort supported by C&Q EPC teams, Engineering, Operations, and external vendors and contractors.
  3. Plan and schedule the commissioning activities according to the C&Q strategy and supporting Validation Plans.
  4. Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
  5. Support development of C&Q schedule by including the activities relevant for the preparation of commissioning test plans and test specifications.
  6. Coordinate the planning and scheduling of commissioning activities with the construction interface and with other disciplines (HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.).
  7. Guide the C&Q documentation preparation effort to ensure correctness, completeness and alignment across different areas/systems.
  8. Lead the preparation activities for commissioning activities start-up.
  9. Coordinate and interface with vendors for C&Q execution related activities, ensuring execution is completed in accordance with CORP-35 principles.
  10. Guide and oversee the Commissioning field execution, including protocols execution.
  11. Coordinate the interface of test specifications.
  12. Lead coordination meetings to fine-tune the commissioning preparation and execution with all involved parties.
  13. Report C&Q status, progress and issues during project stakeholders meetings (e.g. Tier 1 meetings, Wall meetings).
  14. Generate, review, approve CQV test scripts in accordance with Verification Plans and any applicable site commissioning or validation plans or procedures.
  15. Ensure discrepancies encountered are adequately reviewed and approved, tracking these deficiencies, including planning and executing the remediation actions.
  16. Assist the C&Q Manager with the Handover and Release process.
  17. Lead the management of change for his area elements and ensure that the change is controlled, communicated and implemented in the most cost-effective and timely manner.
  18. Support the commissioning field team with specific process tasks.
  19. Ensure C&Q field execution is completed safely and following HSE standards.
  20. Liaise with Construction on design and construction issues.
  21. Participate in construction walk-downs and punch-listing of these systems for Mechanical Completion.
  22. Ensure that quality standards are followed during C&Q execution, with no significant observations in external regulatory inspections for allocated process area.
  23. Support the C&Q execution team as Kneat Super User.

Profil
Your profile:

  1. University degree in Engineering, Chemistry or another relevant discipline.
  2. At least 1 year of experience in Qualification and Validation of equipment.
  3. Applied technical understanding of manufacturing or laboratory equipment; processes specific to Pharmaceutical manufacturing preferred.
  4. Applied Knowledge of creation and verification of qualification equipment plans (FAT/SAT/DQ/IQ/OQ/PQ).
  5. Analytical and structured working style; strong attention to detail.
  6. Ability to effectively work as part of a multidisciplinary, international team.
  7. Hands-on personality, with flexibility and dedication to maximize our client’s value.
  8. Fluency in English is required; German or French would be a plus.
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