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Thermal Validation

Toronto, ON
Thermal Validation Project Manager
PharmEng Technology is currently seeking a Thermal Validation Project Manager for a project in Toronto, ON.  The position is available immediately conditional of a successful interview.
Job Description:
  • Prepares, reviews and executes thermal validation projects: Autoclaves, SIPs of Equipment, Depyrogenation Ovens, Tunnels etc
  • Prepares, reviews and executes Qualification of Utilities/ Facilities (ie Manufacturing Equipment, Packaging Equipment, HVAC, PW, WFI, Clean Steam, CO2, Nitrogen, Compressed Air, Clean Rooms ) qualification protocols, prepares/reviews qualification reports and other relevant documents as they pertain to specific validation requirements
  • Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other regulatory requirements
  • Perform collection of environmental samples for viable and non-viable particulatesLiaise with QC Microbiology, Facilities, Manufacturing and other departments for execution
Job Requirements:
  • Minimum 5+ years' of experience in a similar or related role in the Pharmaceutical or Biotechnology industry
  • Expert ability with developing and executing validation protocols, specifically Thermal validation and Kaye experience
  • Excellent communication skills both written and oral, organizational and technical skills with strong leadership and problem solving abilities
  • Perform thermal validation activities for autoclaves, TCUs, bioreactors, SIPs/CIPs, etc
  • Investigate and troubleshoot problems which occur during the validation studies
  • Maintain an up-to-date knowledge of validation requirements, practices, and procedures
  • Write validation plans related to specific projects and facilities
  • Conduct validation risk assessments related to specific projects and facilities
  • Write and review validation policies and procedures
  • Clearly demonstrate an extensive understanding of quality and regulatory compliance as well as the application of these concepts
  • Independently solve problems of moderate complexity and scope
  • Have the capacity to demonstrate ability to plan and execute appropriately on moderately advanced tasks and/or projects within their technical expertise
  • Have a proven ability to lead projects and/or teams on projects of moderate complexity and scope
  • Effectively influence others on project teams regarding quality or compliance concerns
  • Have the knowledge to conduct presentations of quality issues, initiatives and projects
  • Participate in a regulatory inspection or due diligence activities, as requested
  • Be able to author, review, and /or approve Policies, SOPs, Work Instructions, forms and templates
  • Coordination of multiple validation project activities 

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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