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CQV Project Manager

  1. United States
  1. Contract
Competitive
24151
  1. CAPEX Projects
Date Posted10 Jan 2020
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.
 
Requirements:
  • 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.



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