Senior Validation Engineer – Sterile Manufacturing & Quality Validation

Senior Validation Engineer – Sterile Manufacturing & Quality Validation Location

Toronto, ON, Canada (Hybrid)

Permanent Job

We are seeking an experienced Senior Validation Engineer to support a large‑scale pharmaceutical manufacturing expansion project focused on sterile manufacturing operations. This role will play a critical part in validation, environmental monitoring, sterility assurance, and quality oversight activities associated with a new aseptic filling facility and supporting infrastructure.

The successful candidate will provide technical leadership for environmental monitoring validation, isolator qualification, aseptic process simulation studies, and equipment qualification while ensuring compliance with current GMP regulations and industry best practices.

• Lead the development, execution, and reporting of Environmental Monitoring (EM) validation programs for sterile manufacturing facilities.
• Serve as Subject Matter Expert (SME) for isolator qualification activities, including FAT, SAT, IQ, OQ, and PQ.
• Design and execute validation strategies covering:
  • Viable and non‑viable particle monitoring
  • Pressure differential qualification
  • Airflow visualization studies
  • Smoke studies
  • Cleanroom qualification
• Develop and validate EM sampling plans, alert limits, action limits, and trend analysis programs.
• Collaborate with Engineering, Manufacturing, and Microbiology teams to integrate validation activities into facility start‑up and commissioning schedules.

• Lead the design, execution, and reporting of Media Fill studies to support sterility assurance programs.
• Develop APSS protocols, acceptance criteria, and sampling strategies aligned with regulatory expectations.
• Coordinate APSS campaigns with Manufacturing and Microbiology teams.
• Monitor process parameters, environmental monitoring data, and microbiological results during studies.
• Analyze outcomes, identify trends, and recommend corrective or preventive actions when required.
• Maintain APSS lifecycle documentation, periodic requalification plans, and continued process verification activities.

• Support qualification activities for filling equipment, isolators, RABS, utilities, and other process equipment.
• Review and approve validation deliverables including:
  • User Requirement Specifications (URS)
  • Risk assessments
  • Validation plans
  • Qualification protocols and reports
  • SOPs
  • Executed data packages
• Support process validation activities and equipment registration activities.
• Review and assess deviations, change controls, investigations, and CAPAs associated with validation programs.

• Provide quality oversight for sterility assurance, utilities validation, and computerized systems validation activities.
• Participate in project teams and provide guidance on GMP compliance and validation requirements.
• Maintain awareness of evolving regulatory expectations and industry best practices.
• Identify opportunities for continuous improvement through quality metrics and trend analysis.
• Deliver training and coaching related to validation procedures and compliance requirements.
• Ensure all activities comply with applicable GMP, safety, and quality standards.

• Bachelor's degree in Science, Engineering, Pharmaceutical Sciences, Microbiology, or a related discipline.
• 7–10 years of experience within GMP‑regulated pharmaceutical environments.
• Strong experience in sterile manufacturing and aseptic processing environments.
• Hands‑on experience with isolator qualification and validation.
• Proven experience in environmental monitoring validation and cleanroom qualification.
• Demonstrated experience designing and executing Aseptic Process Simulation Studies (Media Fills).
• Experience qualifying filling equipment, isolators, RABS, utilities, and related process equipment.
• Strong knowledge of:
  • EU GMP Annex 1 (2022 revision)
  • USP
  • USP
  • FDA Aseptic Processing Guidance
  • Health Canada GMP requirements
• Excellent technical writing and documentation review skills.
• Strong problem‑solving, risk assessment, and cross‑functional collaboration abilities.
• Ability to manage multiple validation…