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CQV Project Manager

  1. United States
  1. Contract
  1. CAPEX Projects
Date Posted10 Jan 2020

This vacancy has now expired

CQV Project Manager required for a leading biologics manufacturer on the East Coast of the US!

Exciting opportunity to work for a world-renowned biotech manufacturer and to be a part of an impressive expansion project.

The site is starting commissioning now and requires a Project Manager to take control of the full CQV masterplan on behalf of the Global group. You will be joining a full-scale biotech manufacturing plant, responsible for end-to-end capabilities.

Duties Include:

  • Managing the commissioning/qualification disciplines.
  • Prepares and keeps up-to-date the pre-commissioning and commissioning execution plans (including the schedule and the mobilization of personnel and equipment).
  • Develop Commissioning/Qualification Schedule, harmonization with overall project schedule in line with Global Group.
  • Supervises the preparation of the operation and performance tests and of the operating manuals with the process team + manufacturing associates.
  • Develop, plan and execute Commissioning/Qualification concept/strategy (CQP, Structure of Documents, Commissioning/IQ/OQ/PQ); Standardization of all commissioning/qualification documents.
  • Responsible for the availability of all necessary and requested commissioning and qualification documentation and execution according to the overall project schedule.
  • Assists the Global Project Manager in contacts with User representatives for the handover of the plant.
  • Responsible for all C&Q results and strive for final evaluation.
  • Ensures the preparation of final summaries reports or certificates.
  • CQV Project Management experience within a large-scale mammalian cell culture facility.
  • Experience leading multi-disciplined Engineering groups (CQV, CSV, Manufacturing).
 If this role is of interest, please apply now.

The candidate must have the rights to work in the location stated in the job advert.

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