C&Q Method Lead

Commissioning and Qualification Method Lead
PharmEng Technology is currently seeking a Commissioning and Qualification Method Lead for a project in Toronto, ON.  The position is available immediately conditional of a successful interview
Job Description:
  • Lead a team of CQ Methods consultants to deliver a set of Design Qualifications (DQs) and Factory Acceptance Tests (FATs) in a timely manner.
    • Planning protocol preparation and/or report, review and approval
    • Execution of approved protocols
    • Review of executed results and closure of data packages
    • Ensuring all punch list items are closed, if not transferred to Fieldwire
  • Lead the timely compilation, review and approval of Vendor and Construction Turnover Documentation (V/CTOD) packages.
  • Pre- and post-review and approve all commissioning related testing documentation of non-GxP systems. 
  • Closely coordinate with the Construction Management Company to:
    • Ensure construction related documentation and testing strictly follows established quality procedures/practices and approved protocols
    • Coordinate and facilitate the executions of Installation Verifications
  • Represent CQ Methods on all CQV Work Stream meetings and deliver all agreed upon action items. 
  • Support all CQ Methods related activities such as:
    • Issuing and updating Project Specific Procedures (PSPs)
    • Planning and delivering day to day CQ Methods activities
    • Maintenance of all CQ related documentation and training records
    • CQ phase document development, review and approval
    • Change control and deviation management processes
    • Non-product dependent Performance Qualification activates
    • Coordination of Function and Component Criticality Assessments      
  • Lead the timely compilation, review and approval of Engineering Turnover Packages.
  • Accountable for ensuring all applicable safety procurers and practices are followed by all members of the CQ Methods team.
Job Requirements:  
  • Degree in Science or Engineering
  • 5+ years’ hands-on/field experience in commissioning and qualification of pharmaceutical facilities.
  • Demonstrated experience in coordinating project activities.
  • Demonstrated ability to work as a team member, and in a fast paced environment.
  • Strong interpersonal skills.
  • Excellent problem solving and troubleshooting abilities.
  • High level of familiarity with Excel, Word, and Microsoft Project, required.
  • Proven organizational, time management, and project management skills.
  • Excellent oral and written communication skills.
Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.
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