Validation and Compliance Specialist

1 month ago

Toronto, Ontario, Canada Sotera Health Full time

About the Role:

We are seeking an experienced Associate Validation Engineer to join our team at Sotera Health. In this role, you will be responsible for providing management with information and data on all key aspects of each customer's validation project.

Duties and Responsibilities:

  • Plan, organize, and coordinate customer validation activities at the facility.
  • Write validation protocols and final reports supplied by the facility.
  • Review and approve customer or consultant supplied validation or test protocols for execution within the limitation of the facility's equipment and Sterigenics operating procedures and compliance with current regulatory standards.
  • Execute 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 Sterigenics procedures and traceable to NIST.
  • Provide support to Maintenance or Engineering in the performance of 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.

Supervision Given:

  • No supervision of others is required.

Education, Experience, & Skill Required:

  • Bachelor's degree in a science-related field (or international equivalent) and/or 4-6 years of equivalent experience.
  • 2-4 years of 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, but internal training will be given.
  • Ability to lift a minimum of 50 lbs (23kg) and perform repetitive bending and lifting motions over a period of time.
  • Ability to work a flexible schedule including weekends and holidays if necessary.
  • Ability 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).
  • Ability 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.

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