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Validation Engineer Associate

2 months ago

Toronto, Ontario, Canada Sotera Health Full time

**Job Summary**

Sotera Health is seeking a highly skilled Associate Validation Engineer to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our sterilization processes.

**Key Responsibilities**

  • Plan, organize, and coordinate customer validation activities at our facility, ensuring seamless execution and timely completion.
  • Develop and execute validation protocols, final reports, and other documentation to meet regulatory requirements and company standards.
  • Review and approve customer or consultant-supplied validation or test protocols for execution within our facility's limitations and compliance with current regulatory standards.
  • Lead the execution of validation protocols and technically driven customer projects, including scheduling project runs, ancillary resources, lab testing, and sample handling.
  • Ensure all validation calibration activities are performed according to our procedures and traceable to NIST.
  • Collaborate with Maintenance or Engineering to perform IQ/OQ/PQ activities of new or existing facility equipment.
  • Responsible for annual equipment re-commissioning (sterilization and laboratory).
  • Update validation status in relevant systems.
  • May be required to assist with corrective action and validation process improvement activities.

**Requirements**

  • Minimum BA or BS in a science-related field (or international equivalent) and/or 4-6 years equivalent experience.
  • Two (2) to four (4) years experience in the pharmaceutical, food, or medical device industry with GMP/GLP knowledge a plus but not required.
  • Direct experience in sterility assurance or products sterilization a plus but not required.
  • Experience in writing and executing validation protocols preferred.
  • Customer service and project management experience desired.
  • ISO 9000 experience a plus.
  • Excellent written and verbal communication skills.
  • Strong computer skills.
  • Forklift driving experience preferred, however internal training will be given.
  • Must be able to lift a minimum of 50 lbs (23kg) and perform repetitive bending and lifting motions over a period of time.
  • Must be able to work a flexible schedule including weekends, holidays (if necessary).
  • Must be able to travel 10-20% to various locations as needed.

**Special Requirements**

  • Must possess a thorough understanding of US FDA Quality Systems Regulations, ISO 9000 regulations, and international regulatory requirements.
  • Knowledge and experience working with the FDA and/or international requirements for medical devices is essential.
  • Knowledge of regulatory affairs for FDA (or international equivalent) registered medical device or pharmaceutical manufacturer and direct experience with conducting or participating in FDA (or international equivalent) or supplier audits.
  • Experience in document control to satisfy all ISO 9000 and FDA (or international equivalent) Quality System requirements.
  • Must be medically approved for respirator use (EO).
  • Must be able to tolerate exposure to high temperatures and high humidity [up to 130F (55C) and 65% RH for 20 minutes] (EO).

**Training Required**

  • Must complete all required training for a 'Quality Assurance Manager' outlined in the training program.