Senior Engineer​/Specialist, Pharmaceutical Validation

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.

• 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.

• Bachelor’s or master’s degree in science, engineering, or another relevant discipline.
• Minimum of 5 years of experience in the pharmaceutical industry, in a manufacturing setting, or in consulting.
• Strong knowledge of Good Manufacturing Practices (GMP).
• Knowledge of pharmaceutical manufacturing processes.
• Willingness to travel to client sites.

• Competitive salary commensurate with experience and industry standards.
• Comprehensive group health insurance coverage from day one (medical, dental, vision, childcare).
• Employer‑contributed RRSP plan at 4%.
• Hybrid work mode, with a minimum of 2 days per week in the office.
• Professional development support (e.g., APEGA, APEGS, EGBC) covered by the company.
• Mentorship programs, training, cross‑department opportunities.
• 3 weeks of regular vacation with 1 week of paid vacation during the Christmas holidays and 1 week of personal/sick leave.
• Team‑building activities (Lunch & Learn sessions, team retreats, outdoor activities, family get‑together, workshops).
• Public transport and telephone reimbursement.