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CQV Engineer

  1. United States
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
15-09-2023
31530
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CQV Engineer – Life Science – Contract – Florida

Our client is a leader in helping address some of the world’s biggest science, health, and environmental challenges. The company work together to accelerate research, solve complex analytical challenges, improve patient diagnostics, drive laboratory productivity and produce life-saving treatments for patients.

CQV Engineer Responsibilities:
  • Generation of list of C&Q tests (Installation Verification (IV)/Installation Qualification (IQ), Operational Verification (OV), Operational Qualification (OQ), Performance Testing (PT) and Performance Qualification (PQ).
  • Generation of validation documentation during the decommissioning process.
  • Execution of process commissioning & qualification tests in adherence with decommissioning project schedule.
  • Retains sole ownership and responsibility for commissioning and qualification documents from generation, through pre-approval, execution, post-execution review and final sign-off.
  • Supporting validation activities and CIP/Cleaning verification during the handover of the decommissioned shell.
About you:
  • Demonstrated knowledge in Commissioning, Qualification and/or Validation (CQV) with experience in Bio-process manufacturing operations.
  • Experience writing protocols/reports, performing execution of activities associated with process equipment used in manufacturing, troubleshooting or mitigation of discrepancies
  • Experience providing technical assessments for deviations, risk assessments, CAPAs, GMP investigation and change controls, assessing proposed changes to validation process to identify requirements necessary to maintain validation status.
Are you a good fit for a CQV Engineer? Get in touch with us today.

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

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