Senior MES Quality Validation Specialist

Amaris Consulting | Part of Mantu; Toronto; Sur place; CAD 70 000 - 110 000; Plein temps

Résumé du poste

Amaris Consulting, part of Mantu, is seeking a Senior MES Quality Validation Specialist for its Toronto Quality Validation unit. You will act as the Quality approver for MES changes and oversee validation activities across the manufacturing and IT interfaces, ensuring compliance and inspection readiness.

You will review validation deliverables, authorise releases, and collaborate with QA, Manufacturing, Automation, and Engineering to maintain a validated state.

Qualifications

• 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 PharmaSuite 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 (TrackWise, Veeva Vault or similar).
• Direct involvement in Health Canada, FDA or EMA inspections.
• Fluent written and spoken English.

Responsabilités

• 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.

Connaissances

GxP validation

Quality Assurance

Regulatory compliance

Change control

Risk assessment

Documentation control

Formation

Bachelor's degree in Engineering, Life Sciences, or Computer Science

Outils

Werum PAS-X

Emerson Syncade

Rockwell PharmaSuite

DeltaV DCS

OSISoft PI Historian

Description du poste

Job Description

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

Key Responsibilities

Change Control and Validation Strategy

• 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

Protocol Review and Execution Oversight

• 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

Compliance and Data Integrity

• 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

Collaboration

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

Required Qualifications

• 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 PharmaSuite 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 (TrackWise, Veeva Vault or similar)
• Direct involvement in Health Canada, FDA or EMA inspections
• Fluent written and spoken English

Nice to Have

• 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

Expected Compensation Range

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.

Canadian Experience Requirement

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

Artificial Intelligence (AI) Disclosure

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.

Statement Regarding Job Vacancy

This position is a Job creation, created to support ongoing project needs.

Recruitment Process & Feedback Timeline

Candidates will receive feedback on their application within a maximum of 45 days from the date of application or from their most recent interview stage.

Why choose us

• An international community bringing together more than 110 different nationalities
• An environment where trust is central: 70% of our leaders started their careers at the entry level
• A strong training system with our internal Academy and more than 250 modules available
• A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting, part of Mantu is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews: (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!