Freelance CQV Engineer

Freelance CQV Engineer.

Freelance CQV Engineer

Massachusetts

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Contract

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CQV

Duties:

  • Create validation plans.
  • Perform and document impact and risk assessments, evaluating direct, indirect, and non-impact systems in complex processes.
  • Maintain detailed records of qualification, validation, and change control activities for compliance audits.
  • Write, edit, and execute technical commissioning, qualification, and validation documentation for equipment, systems, software, and processes under project leader guidance.
  • Run test scripts and document results.
  • Adhere to project schedules for assigned tasks.
  • Conduct user interface testing, software verification, and alarm testing on automated systems.
  • Develop, review, and execute testing documentation.
  • Recommend design or process modifications based on test results.
  • Understand validation documents, URS, IQ, OQ, and PQ.

Your profile:

  • 5-7 years of proven CQV experience in GMP-regulated environments.
  • Must have experience in Cleaning Validation.
  • Strong business maturity and interpersonal skills for effective communication and collaboration.
  • Ability to clearly communicate requirements with rationale to various levels within the client's organization.
  • Demonstrated attention to detail and organization in project work.
  • Ability to work independently on assigned tasks.
  • Training in GMP and Good Documentation Practice (can be completed during onboarding).
  • Intermediate proficiency in WORD (creating/editing large technical documents with styles, tables, TOCs, track changes).
  • Basic proficiency in EXCEL and PowerPoint.
  • Strong interpersonal skills and clear communication abilities.

    If you are interested please send your CV to James.Gregory@darwinrecruitment.com

Darwin Recruitment is acting as an Employment Business in relation to this vacancy.

James Gregory

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