Job Description

BWXT Medical Ltd. provides its customers, who conduct life-saving medical procedures for patients around the world, the benefit of decades of experience in the development, manufacturing, packaging and delivery of medical isotopes and radiopharmaceuticals. Headquartered in Kanata, Ontario, BWXT Medical Ltd. employs over 300 highly-skilled people in Kanata and Vancouver, British Columbia. BWXT Medical Ltd. is part of the BWXT nuclear power segment (NPG) of BWX Technologies, Inc.

Validation Specialist

We are recruiting a Validation Specialist to implement new sterilization and process equipment for our facility in Kanata, Ontario.

Responsibilities:

Working within the Engineering team and Validation Technicians, you will:

• Assist to develop and validate an autoclave sterilization process for a radiopharmaceutical products
• 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 equipment including autoclaves, depyrogenation ovens and electron beam
• 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 including but not limited to dose calibratory, vial washers, WHP Systems, etc.

Qualifications & Experience:

• 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 validating dose calibrators
• 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.

Why join BWXT Medical?

• Work within the growing and exciting nuclear medicine industry as well as with highly skilled employees.
• Competitive salaries.
• Company match pension plan.
• Comprehensive health and dental benefits.
• Education Reimbursement Program.
• Life insurance.
• Collaborative work environment... and so much more!

BWXT Medical Ltd. embraces diversity of thought, values individuality, encourages new perspectives and provides equal opportunity in employment for all qualified employees and applicants without regard to race, national or ethnic origin, colour, religion, age, sex, sexual orientation, marital status, family status, disability, a conviction for which a pardon has been granted or a record suspended or any other category protected by federal law.

BWX Technologies