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CQV Lead

2 months ago

Greater Toronto Area, Canada Trinity Consultants - Advent Engineering Full time
CQV Lead Job Description

ADVENT Engineering is seeking a highly skilled CQV Lead to join our team in GTA, Canada. As a CQV Lead, you will be responsible for leading and/or working with cross-functional teams to complete all C&Q deliverables for assigned workstreams.

Key Responsibilities:

  • Lead and/or work with cross-functional teams to complete all C&Q deliverables for assigned workstreams.
  • Work with health and safety and construction company to ensure compliance with regulations.
  • Compliance liaison between quality and commissioning teams to ensure quality and adherence to best practices are followed.
  • Track and manage generation, investigation, and resolution of any punch lists, deviations, change controls, or CAPAs.
  • Forecast, track progress, and completion of CQ deliverables.
  • Develop/update project governance documents, strategies, risk assessments, and user specifications.
  • Ensure all CQ documents (protocols, risk assessments, reports) are completed on time.
  • Plan, prepare, and coordinate completion of all CQ activities for specific workstreams.
  • Coordinate all CQ resources for execution readiness.
  • Review and approve CQ documents (protocols, risk assessments, executed raw data packages, and reports).

Qualifications:

  • Requires a bachelor's or master's degree in scientific (biotechnology) or engineering (mechanical, chemical, or biochemical engineering) with years of experience in the biotech/pharmaceutical academic or industrial environment.
  • Basic knowledge of process/GxP equipment for fill, finish, inspection, and packaging equipment.
  • Basic knowledge of cycle development for autoclaves and VHP.
  • Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations.
  • Basic technical writing with proficiency in KNEAT, Excel, PowerPoint, Visio, Word, SharePoint, etc., in addition to experience working within shared work environments.
  • Basic knowledge of commissioning and qualification.
  • Basic knowledge of using a Kaye validator or data loggers.
  • Basic knowledge of DeltaV.

Requirements:

  • Experience in GMP pharmaceutical and/or biotechnology facilities in design, engineering, quality, or manufacturing is a must.
  • Interested candidates with direct related experience in US or Toronto locations are encouraged to apply.