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CQ Lead

  1. West Coast
  1. Contract
  1. Commisions, Qualification and Validation
Date Posted06 Jan 2021
CQ Lead - 6 months - San Francisco

Excellent contract opportunity for a CQV engineer to lead the commissioning and qualification team of a multimillion dollar Bio-pharmaceutical capital project in the heart of San Francisco.

Our client is looking for an individual to be responsible for:
  • Supporting the development of the project C&Q master plan, identify task lists and project time lines in line with the objectives and goals of the projects, and propose sub-plans to facilitate the C&Q process, and eliminate road blocks.
  • Leading the project teams to develop the overall C&Q phase project plan and schedule which includes risk assessment, design review/DQ, test matrix, FAT, SAT/commissioning, installation, operational and performance qualification for all systems.
  • Aid with the C&Q cost and schedule planning and control process.
  • Work closely with the contractor to help align the C&Q program with the construction program
  • Ensure the successful handover to process validation activities.
  • Lead a C&Q team (technical writers, commissioning engineers, interfaces to calibration and system owners) and manage day-to-day C&Q activities.
  • Work closely with Automation/IT, Quality, Compliance and Technology Leads to ensure readiness for facility, process and clean utilities commissioning and qualification
  • Ensuring C&Q program alignment with companies engineering best practices.
  • Manage relevant project documentation
  • Managing commissioning and qualification phase improvement (lessons learned, deviation management and resolution, etc.)

The requirements for this role:
  • BS Engineering or Science (or equivalent experience)
  • 8 years project experience in a CQ, Validation Role.
  • Previous Biologics greenfield or brownfield experience in RV, IV and IQ generation (ASTM E2500 based approach) and execution an advantage
  • Demonstrated leadership and people management skills.
  • Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification
  • Good written and verbal communication skills with both technical and non-technical staff
If you have the right skill set for this role and would be interested in working for a bio-pharmaceutical market leader get in touch today!

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

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