Computerized Systems Validation Specialist

GENAIZ

CSV Specialist managing computerized systems validation for clients in the life sciences sector. Collaborating with diverse stakeholders on compliance and technology deployment.

Posted 6/25/2026full-timeMontréal • 🇨🇦 CanadaJuniorMid-LevelWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

validation strategiesrisk analysesqualification processtest scriptsSoftware Development Life Cycle (SDLC)validation planstraceability matricesqualification protocolsStandard Operating Procedures (SOPs)GxP compliance

Soft Skills

communication skillsinterpersonal skillsmotivatedproactiveorganizeddetail-orientedinitiativefluent in Frenchfluent in English

Industry Keywords

life sciencespharmaceutical industry21 CFR Part 11GMP compliancestakeholder coordinationclient trainingdeviations resolutionautomated systemsquality unitSMEs

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Perform reviews and verifications of commissioning, qualification, and validation documents for clients' systems and processes
Coordinate CSV projects for software and automated systems
Develop validation strategies and plans
Coordinate activities among stakeholders (IT department, SMEs, end users, quality unit, vendors)
Perform risk analyses and define the qualification process
Write and review risk assessments and applicable test scripts in accordance with GxP (GMP) compliance guidelines, 21 CFR Part 11, and validation procedures
Prepare and review Software Development Life Cycle (SDLC) deliverables, such as validation plans, requirements, specifications, traceability matrices, test protocols (IQ, OQ, PQ), and qualification reports
Execute and review qualification protocols to ensure compliance with applicable guidelines
Participate in resolving deviations to protocols and procedures
Review and revise Standard Operating Procedures (SOPs)
Communicate CSV approaches and requirements during meetings and workshops
Develop and deliver client training

Requirements

What you’ll need

Fluent in written and spoken French and English
Strong communication and interpersonal skills
Motivated to contribute to the company while actively learning
Proactive and organized
Detail-oriented
Takes initiative
Minimum of 2 years' work experience in the life sciences or pharmaceutical industry
Bachelor's degree in Computer Science (security, infrastructure, software), Engineering (chemical, biomedical, biotechnology, etc.), or Life Sciences (biochemistry, chemistry, pharmacy, etc.)

Benefits

Comp & perks

Competitive base salary + bonus (based on company, team, and individual performance)
Comprehensive insurance coverage through RBC
RRSP (Registered Retirement Savings Plan) contributions
Permanent full-time position
Mobile phone plan reimbursement
Dynamic company culture with career development opportunities
Hybrid work policy (based on team and client needs)
Regular company events