Overview
Senior Pharmaceutical Validation Engineer or Specialist – Greater Toronto Area. The role involves managing validation activities, drafting master documents, executing qualification protocols, ensuring GMP compliance, supporting client QA teams, and managing client accounts. 5+ years of experience in pharmaceutical validation is required.
Responsibilities
- Draft master validation documents such as Validation Master Plan, risk analysis, cleaning matrix, and User Requirements Specification.
- Draft and execute equipment/system (IQ/OQ/PQ), process, and cleaning qualification protocols.
- Coordinate and ensure compliance with GMP during validation activities and general operations.
- Support clients’ QA/Compliance teams in initiating change notices or reporting deviations to trigger CAPA, Change Control, deviations, or other relevant actions.
- Manage client accounts.
Requirements