Senior Validation Engineer (Pharmaceuticals)

TL;DR

Senior Validation Engineer (Pharmaceuticals): Leading validation, environmental monitoring, and quality oversight for a large-scale sterile manufacturing expansion project with an accent on aseptic filling and isolator qualification. Focus on designing and executing Aseptic Process Simulation Studies (Media Fills) and ensuring strict GMP compliance.

Location: Hybrid in Toronto, ON, Canada

Salary: 70K-120K CAD

Company

An independent technology consulting firm providing guidance and solutions in Life Sciences and Engineering to over 1000 global clients.

What you will do

• Lead Environmental Monitoring (EM) validation programs, including viable/non-viable particle monitoring and cleanroom qualification.
• Serve as the Subject Matter Expert for isolator qualification activities (FAT, SAT, IQ, OQ, PQ).
• Design, execute, and report Aseptic Process Simulation Studies (Media Fills) to support sterility assurance.
• Qualify filling equipment, RABS, and utilities, reviewing URS, risk assessments, and validation plans.
• Provide quality oversight for sterility assurance, utilities validation, and computerized systems validation.
• Manage deviations, change controls, investigations, and CAPAs associated with validation programs.

Requirements

• Bachelor's degree in Science, Engineering, Pharmaceutical Sciences, or Microbiology.
• 7–10 years of experience within GMP-regulated pharmaceutical environments.
• Expertise in sterile manufacturing, aseptic processing, and isolator qualification.
• Proven experience designing and executing Aseptic Process Simulation Studies (Media Fills).
• Strong knowledge of EU GMP Annex 1 (2022), USP <1116>, USP <71>, and FDA Aseptic Processing Guidance.
• Excellent technical writing and cross-functional collaboration abilities.

Culture & Benefits

• International community with more than 110 different nationalities.
• Strong internal growth trajectory, with 70% of leaders starting at entry level.
• Comprehensive training system via internal Academy with 250+ modules.
• Dynamic work environment with frequent internal events and team buildings.

Hiring process

• Brief virtual/phone conversation to align motivations and requirements.
• Average of 3 interviews with the line manager and team members.
• Potential case study or technical assessment depending on the role.