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Added 3 days ago
QA Specialist
BWXT
Ottawa, ON
Must have the ability to understand complex operations from a broad perspective
Added 3 days ago
JP
Senior Specialist, Microbiology & Environmental Monitoring
Jubilant Pharma Limited
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
Proficiency with computerized systems (e.g., MODA, SAP, MS Office)
Added 3 days ago
JP
Maintenance Technical Specialist, Equipment and Documentation
Jubilant Pharma Limited
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
Job Title: Maintenance Technical Specialist, Equipment and Documentation
Added 3 days ago
JP
Spécialiste, Validation / Specialist, Validation
Jubilant Pharma Limited
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
Job Title: Spécialiste, Validation / Specialist, Validation
Added 3 days ago
JP
Validation Specialist
Jubilant Pharma Limited
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
The Validation Specialist is responsible for developing, coordinating, and executing qualification and validation activities related to equipment, systems, utilities, cleaning processes,…
Added 3 days ago
JP
Spécialiste, Validation AQ et gouvernance des données / Specialist, QA Validation & Data Governance
Jubilant Pharma Limited
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
Provide QA oversight for validation and qualification activities, including processes, equipment, facilities, utilities, and computerized systems.
Added 4 days ago
LC
Senior Specialist, Quality Assurance
Loblaw Companies Limited
Toronto, ON
- Full-time
Must have a Bachelor of Science (or Canadian Equivalent)
Added 4 days ago
SD
Senior Specialist, Quality Assurance
Shoppers Drug Mart
Toronto, ON
- Full-time
Must have a Bachelor of Science (or Canadian Equivalent)
Added 10 days ago
AA
Spécialiste en fiabilité / Reliability Specialist
Airbus Aircraft
Montreal, QC
- Full-time
Gestion contractuelle et conformité : Assurer le suivi rigoureux des contrats de maintenance, incluant la validation des rapports d'intervention et le respect des indicateurs de performance…
Added 13 days ago
AC
Senior MES Quality Validation Specialist
Amaris Consulting | Part of Mantu
Toronto, ON
- Full-time
3+ years in validation or Quality within GMP pharmaceutical or biologics manufacturing, including at least four years on computerized systems (CSV)
Added 19 days ago
MD
Office and Data Entry Student Worker, Student Worker Clerical
Minnesota Direct Care and Treatment
Saint-Paul, NB · St.-Paul, NB
- Part-time
Work Shift/Work Hours: Day Shift / 24 hours per week between 8:00 a.m
Added 19 days ago
R
Laboratory GxP Systems Specialist II
Replimune
Montreal, QC
- Full-time
The Laboratory GxP Systems Administrator is responsible for the administration, maintenance, compliance, and support of laboratory computerized systems used within a regulated GxP…
Added 19 days ago
M
Spécialiste principal(e), validation des systèmes informatisés – Qualité / Senior Specialist, Quality Computer Validation (contrat 18 mois)
McKesson
Montreal, QC
- Full-time
The Senior Specialist, Quality Computer Validation supports the validation and ongoing compliance of GxP computerized systems, software, computerized equipment and, where required,…
Added 20 days ago
BP
Bilingual Accounts Payable Specialist
BlueSky Personnel Solutions
Toronto, ON
- $40 to $43 CAD / hour
- Temporary
Hybrid: (Work from home 3 days per week) · The ideal candidate will/must have:
Added 22 days ago
JR
Spécialiste Validation / Validation Specialist
Jubilant Radiopharma
Kirkland, QC
- Full-time
The Validation Specialist is responsible for developing, coordinating, and executing qualification and validation activities related to equipment, systems, utilities, cleaning processes,…
Added 23 days ago
TERM - Specialist I, QA Validation
Emergent Biosolutions
Winnipeg, MB
Apply Global GxP requirements as part of a pragmatic validation strategy for computerized systems
Added 29 days ago
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Specialist II, Validation
Resilience
Mississauga, ON · CAN - ON - Mississauga - Meadowpine Blvd
- $70,000 to $96,250 CAD / year
- Full-time
Prepare and execute Validation Protocols (IQ/OQ/PQ/PV/CV) for new and existing equipment, utilities, facility systems, computerized systems, processes, and cleaning, in accordance with…
Added 29 days ago
A
Senior CSV Validation Engineer - Pharma industry
ALGOBRAINZ
ON · Ontario, Canada
- Contract
Our client is seeking a Senior CSV Validation Specialist dedicated to Building Management System validation activities. This is an on-site role supporting a regulated pharmaceutical…
Added 1 month ago
Payroll Accounting Specialist - Alberta Sheriffs Police Service
Government of Alberta
Calgary, AB
Must have Canadian payroll experience, preferably experience with Alberta payroll and general ledger processes
Added 1 month ago
AC
MES Quality Validation Specialist
Amaris Consulting | Part of Mantu
Toronto, ON
- Full-time
3+ years in validation or Quality within GMP pharmaceutical or biologics manufacturing, including at least four years on computerized systems (CSV)
Added 1 month ago
NS
Medical Laboratory Technical Specialist, Transfusion Medicine
Nova Scotia Health Authority
Halifax, NS
- Full-time
…instruments that are often computer integrated and networked and uses computerized information systems. Compares test results to pre-established criteria (reference intervals) and makes…
Added 1 month ago
M
Senior Specialist, Quality Computer Validation (18 month contract)
McKesson
Mississauga, ON
- Full-time
Reporting to the Senior Manager, Corporate Quality Systems & CSV, the Senior Quality Computer Validation Specialist will be responsible for supporting validation activities for computerized…
Added 1 month ago
JP
Spécialiste technique, maintenance, équipements et documentation / Maintenance Technical Specialist, Equipment and Documentation
Jubilant Pharma Limited
Montreal, QC
- Full-time
Coordonner les contributions des équipes de maintenance, ingénierie, production, validation, qualité et HSE.
Added 1 month ago
JP
Spécialiste junior, Validation des systèmes informatisés (CSV) et intégrité des données / Junior Specialist, Computerized Systems Validation (CSV) and Data Integrity
Jubilant Pharma Limited
Montreal, QC
- Full-time
Reporting to the Director, Quality Control, the Junior Specialist, Computerized Systems Validation (CSV) and Data Integrity supports the deployment, implementation, and maintenance of…
Added 1 month ago
A
Specialist, Compliance
API
Edmonton, AB
- Full-time
Coordinate with Validation, Engineering, Production, QA, and Technical Operations to ensure qualification activities are appropriately linked to approved procedures, equipment status,…

Amaris Consulting | Part of Mantu

MES Quality Validation Specialist

Toronto, ON, Canada

Full-time

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Applications open in a new tab.

Job details

Job type: Full-time
Posting language: English
Posted: Oct 13, 2026

Original job description

We are looking for a 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, escalate 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.

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More about this job

Responsibilities

Review and approve MES change controls, risk-based validation strategies, protocols, test results, and validation documentation for MES and its DeltaV DCS and PI Historian integrations. Resolve validation issues, authorize return to service, maintain data integrity and inspection readiness, and collaborate with cross-functional teams to keep systems in a validated state.

Requirements

Requires a bachelor's degree in a relevant discipline and substantial experience in GMP pharmaceutical or biologics manufacturing and computerized system validation, including hands-on approval of MES validation. Candidates should have expertise in GAMP 5, 21 CFR Part 11, EU GMP Annex 11, data integrity, deviation investigations, and regulatory inspections, with working knowledge of DeltaV DCS and PI Historian.

Skills

MES Validation
Computerized System Validation
GMP Compliance
Risk-Based Validation
GAMP 5
IQ/OQ/PQ
Change Control
Protocol Review
Deviation Investigation
Root Cause Analysis
Data Integrity
21 CFR Part 11
EU GMP Annex 11
DeltaV DCS
PI Historian
Quality Assurance

Visa sponsorship

Not detected in the job text

Keywords

Manufacturing Execution System
MES
Werum PAS-X
Emerson Syncade
Rockwell PharmaSuite
Computerized System Validation
CSV
GMP
GAMP 5
IQ
OQ
PQ
DeltaV DCS
OSIsoft PI Historian
21 CFR Part 11
EU GMP Annex 11
ALCOA+
Data Integrity
Change Control
TrackWise
Veeva Vault
Deviation Investigation
Root Cause Analysis
Regulatory Inspections
Health Canada
FDA
EMA
Computer Software Assurance
CSA
Validation Protocols

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Jobs in Canada