Senior MES Quality Validation Specialist

We are looking for a

We are looking for a Senior MES Quality Validation Specialist to join its Toronto Quality Validation unit. The team reviews and approves validation documentation and protocols across the manufacturing and supply organisation. In this role, you will act as the Quality approver for changes to the Manufacturing Execution System (MES) and its integrations with the DeltaV DCS and PI Historian. Your work will keep a major digital project on schedule while the internal team is at capacity, and will keep every change compliant and inspection-ready.

Location:

Toronto, Ontario

Work Mode:
Onsite

• Review and approve MES change requests, assessing validation impact, risk and GxP compliance requirements
• Define and approve risk-based validation strategies (IQ, OQ, PQ) for MES enhancements and system modifications
• Verify the completeness of validation deliverables, traceability matrices and change control records before implementation

• Review and approve validation protocols, test scripts and executed results for MES, DeltaV DCS and PI Historian integrations
• Investigate and resolve validation deviations, discrepancies and testing issues so that validation can close and systems can be released on time
• Authorise MES return to service after successful validation, and confirm updates to SOPs, work instructions and training records

• Ensure compliance with data integrity principles (ALCOA+) and electronic records and signatures regulations, including 21 CFR Part 11 and EU GMP Annex 11
• Identify, upscale and mitigate quality and compliance risks across the computerized system change lifecycle
• Keep validation documentation accurate, complete and inspection-ready, and support regulatory inspections and internal audits

• Work with Quality Assurance, Manufacturing, Automation, Engineering and IT to keep systems in a validated state

• Bachelor's degree in Engineering, Life Sciences, Computer Science or a related discipline
• 3+ years in validation or Quality within GMP pharmaceutical or biologics manufacturing, including at least four years on computerized systems (CSV)
• Hands-on experience approving validation for an MES platform (Werum PAS-X, Emerson Syncade, Rockwell Pharma Suite or equivalent)
• Working knowledge of DeltaV DCS and OSIsoft PI Historian, ideally on integrated MES, DCS and historian interfaces
• Proven experience writing and approving risk-based validation strategies under GAMP 5
• Strong command of 21 CFR Part 11, EU GMP Annex 11 and data integrity expectations
• Experience leading deviation investigations and root cause analysis within a change control system (Track Wise, Veeva Vault or similar)
• Direct involvement in Health Canada, FDA or EMA inspections
• Fluent written and spoken English

• Vaccines or sterile biologics manufacturing background
• Prior role as Quality approver (not only as validation author or executor)
• Exposure to Computer Software Assurance (CSA) approaches
• French language skills

70-110K The final compensation offered will be determined based on the candidate’s level of experience, skills, and qualifications, in compliance with applicable pay transparency requirements.

No Canadian work experience is required for this position. Candidates are encouraged to apply regardless of previous Canadian experience.

No Artificial Intelligence (AI) tools are used in the screening, assessment, or selection of candidates for this position. All stages of the recruitment process are conducted by human recruiters and hiring managers.