PharmEng Technology is currently seeking a Thermal Validation
for a project in ON, Canada. The position is available immediately conditional of a successful interview
- Prepare and execute protocols and prepare final reports for IQ, OQ and/or PQ of basic cell processing equipment such as Incubators, Centrifuges, Freezers, Autoclaves, Depyrogenation Tunnels, etc.
- Perform hands on testing with equipment, process and computer system qualification and validation using data loggers, various instrumentation and computerized equipment.
- Support in the rectification/resolution of deficiencies and non-conformances identified during the qualification
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
- The position requires a minimum B.S/BA in engineering or a related science discipline
- Must have a thorough knowledge of, and experience working in cGMP environments in the biopharmaceutical or pharmaceutical industry
- Must have a thorough understanding and scientific background including Regulatory requirements and industry guidance of temperature controlled systems and moist and dry heat sterilization processes (autoclaves, SIP systems)
- Must have experience with the validation of temperature controlled systems and moist and dry heat sterilization processes (autoclaves, SIP systems)
- Must be able to prepare, URS, FS, protocols and reports for relevant systems
- Must have experience using the appropriate test instruments for performing thermal validation studies.
- Excellent technical writing skills, good oral communication skills, detail orientation, problem solving ability and teamwork are necessary
- Must be a dedicated self-starter with a high energy level and able to achieve results
- Proven record of excellent verbal and written communication skills
- Proven ability to challenge the status quo and regularly think of ways to do things differently together with having strong problem-solving skills
- Ability to comfortably interact and clearly communicate with individuals at all levels of the organization to provide program updates and reviews