Validation Engineer


About this role

We’re hiring a Validation Engineer for our client, a medical isotopes company, to join their team. This is a 1-year contract opportunity


  • Assist to develop and validate an autoclave sterilization process for a radiopharmaceutical
  • Identify optimal parameters to ensure adequate sterilization
  • Provide technical advice as required to prepare, verify and confirm sterilization calculations
  • Generate development, qualification and revalidation protocols for the sterilization cycle and associated autoclaves
  • Analyze and review raw data, troubleshoot system and/or protocol changes as required during validation activities.
  • Assist in troubleshooting, process optimization and continuous improvements
  • Plan and execute activities to ensure project goals are met
  • Conduct site acceptance tests and commissioning of new equipment and facilities
  • Prepare validation paperwork for and respond to inquiries from Regulatory Authorities
  • Provide support and training to production team
  • Oversight of validation for hot cells, fume hoods, cleaning and manufacturing equipment
  • Oversight of validation and development of revalidation protocols for critical manufacturing equipment



  • Bachelor’s degree in relevant Science or Engineering
  • Knowledgeable in steam sterilization in the pharmaceutical industry is required
  • 5+ years within the Medical Device or Pharmaceutical fields
  • Experience with sterilization cycle design of a medical device or pharmaceuticals using autoclaves
  • Experience with Current Good Manufacturing Practices, including IQ/OQ/PQ and Validation Development
  • Experience working with electronic systems that are 21 CFR part 11 compliant is an asset
  • Experience working with automated computerized systems (i.e. PLC, SCADA, etc.) is an asset
  • Strong communication, technical writing and presentation skills
  • Ability to deliver results and meet deadlines
  • Excellent organizational and workload prioritizing skills
  • Knowledge of chemical disinfection in pharmaceutical industry is an asset
  • Experience in the radiopharmaceutical industry is an asset
  • Experience in Hot Cell design is an asset.


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Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
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Any questions remaining?

Your consultant, Maria Camanag is happy to clarify anything about this vacancy. When reaching out, use the pub number:

Account manager

Maria Camanag
Brunel Canada - Toronto

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