Senior MES Quality Validation Specialist (MES)

Location: Toronto, Ontario; onsite

Expected compensation: 70,000–110,000 CAD per year

Company

hirify.global is an independent technology consulting firm providing technology, engineering, information systems, telecom, and life sciences solutions to businesses through an international organization.

What you will do

• Review and approve MES change requests, validation impacts, risk assessments, and GxP requirements.
• Define and approve risk-based IQ, OQ, and PQ validation strategies and verify validation deliverables, traceability matrices, and change control records.
• Review protocols, test scripts, and executed results for MES, DeltaV DCS, and PI Historian integrations.
• Investigate deviations, discrepancies, and testing issues; authorize MES return to service after successful validation.
• Ensure compliance with ALCOA+, 21 CFR Part 11, EU GMP Annex 11, and inspection-readiness requirements.
• Collaborate with Quality Assurance, Manufacturing, Automation, Engineering, and IT to keep systems in a validated state.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related discipline.
• At least 3 years of validation or Quality experience in GMP pharmaceutical or biologics manufacturing, including at least 4 years working with computerized systems validation.
• Hands-on experience approving validation for an MES platform such as Werum PAS-X, Emerson Syncade, Rockwell PharmaSuite, or an equivalent system.
• Experience with DeltaV DCS, OSIsoft PI Historian, GAMP 5, risk-based validation, deviation investigations, and root cause analysis.
• Strong knowledge of 21 CFR Part 11, EU GMP Annex 11, and data integrity expectations, plus direct involvement in Health Canada, FDA, or EMA inspections.
• Fluent written and spoken English and availability to work onsite in Toronto, Ontario.

Nice to have

• Experience in vaccines or sterile biologics manufacturing.
• Previous experience as a Quality approver rather than only a validation author or executor.
• Exposure to Computer Software Assurance approaches.
• French language skills.

Culture & Benefits

• International community representing more than 110 nationalities.
• Internal Academy with more than 250 training modules.
• Trust-focused environment with opportunities for professional development.
• Regular internal events, including afterworks and team-building activities.
• The position is a newly created role supporting ongoing project needs.

Hiring process

• Brief virtual or phone call followed by an average of three interviews, depending on seniority.
• A case study or technical assessment may be required.
• Application feedback is provided within a maximum of 45 days from application or the latest interview stage.