Process Validation & Thermal Validation

 Process Validation
 
 
PharmEng Technology is currently seeking a Process Validation Engineer for a project in Toronto, ON. The position is available immediately conditional of a successful interview.

Job Description:
  • Lead projects large in scope and have full technical responsibility for interpreting, organizing, executing and coordinating projects from small to large in scale.
  • Provide manufacturing process leadership through process improvement and optimization.
  • Development of Validation Plans, Process Qualifications and Aseptic Process Simulations (Media Fills) for various sterile dosage forms.
  • Working with the team to ensure all aspects of activity within the Process development and Validation group adhere to required policies and procedures, including safety and training.
  • Author and execute protocols as well as, writing comprehensive final reports including thorough resolution of protocol discrepancies.
  • Investigate/troubleshoot validation problems, as well as, conduct some statistical analysis of testing results.
  • Responsible for the validation (IQ, OQ, PQ) of various types of equipment systems: validation or requalification of autoclave loads, process equipment, filter integrity tester, depyrogenation oven loads, parts washer, vial washer, wireless temperature data loggers, temperature controlled chambers, lab analytical media fills, and Barrier isolators
  • Experience with sterilization process validation and chamber qualification (Freezer, Refrigerators, etc.) is required.
  • Evaluate new technological solutions determine feasibility, implementation and validation requirements.
  • Must have experience with the generation of deviations and CAPAs.
  •  Highly capable of developing Validation Plans and Process Qualifications
  • Working with a team to ensure all aspects of activity within the Process development and Validation group adhere to required policies and procedures, including safety and training.
  • Author and execute protocols, as well as writing comprehensive final reports including thorough resolution of protocol discrepancies.
  • Investigate/troubleshoot validation problems, as well as, conduct some statistical analysis of testing results.
  • Familiarity with applicable US and worldwide regulatory requirements for the Pharmaceutical/biotechnology industry (i.e. GMP, GLP, etc)
 

Job Requirements: 
  • BS/MS in Engineering or related Science discipline with 5+ years of relevant experience 
  • Experience with validation, and with knowledge of production.
  • knowledge of mixing, filling, filtration and sterilization process as it relates to FDA manufacturing
  • Knowledge of USP, EP, JP and FDA requirements.
  • Proven track-record of leading teams and project management experience is highly desired
  • Knowledge of media manufacturing process is a plus.
  • Familiarity with applicable US and worldwide regulatory requirements for the Pharmaceutical/biopharmaceutical industry (i.e. GMP and GLP).
  • Experience with biopharmaceutical process equipment and moist, dry, and VHP sterilization process validation.
  • Experience with Microsoft Word and Excel.
 
 

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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