Thermal Validation
PharmEng Technology
11d ago
  • 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
  • Apply
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