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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Start applying immediately
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)
Any questions remaining?
Your consultant, Maria Camanag is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel Canada - Toronto
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