Senior CSV Engineer – Validate GxP Computer Systems

Cencora; Edmonton; On-site; CAD 81,000 - 131,000; Full time

Benefits offered by this job

Medical, dental, and vision care

Training programs

Mentorship programs

Job summary

Cencora is seeking a Computer System Validation (CSV) Specialist to lead validation activities for GxP-critical systems, ensuring compliance with PIC/S Annex 11 and 21 CFR Part 11. The role interfaces with IT, QA, and external partners to deliver validated software and documentation.

The ideal candidate has 3+ years' hands-on CSV validation experience in pharma/biotech, with a degree in CS/IT/engineering and strong communication and project-management skills.

Qualifications

• Requires a minimum of three (3) years of hands-on experience validating GxP computerized systems.
• Experience with software development methodologies and working with external vendors is preferred.
• A college or university degree in computer science, information technology, information security, engineering, software programming, or a related discipline is required.

Responsibilities

• Implement CSV strategy and lead validation for GxP systems, ensuring PIC/S Annex 11 and 21 CFR Part 11 compliance.
• Review and develop validation strategies and documentation to support compliance and business objectives.
• Prepare validation packages including validation plans, TRMs, risk assessments, IQ/OQ/PQ, test cases, and reports.
• Manage defects, deviations, and incidents; organize triage meetings and maintain logs through project closure.
• Coordinate validation documentation review, approval, execution, and post-execution review.
• Train validation project teams on testing policies, practices, and tools.

Skills

Communication

Leadership & relationship building

Analytical skills

Organizational skills

Project management principles

Teamwork

Education

Bachelor's degree in CS/IT/Engineering

Tools

Kneat PVP

qTest

JIRA

HP ALM

Microsoft Copilot

Job description

Cencora is seeking a Computer System Validation (CSV) Specialist to lead validation activities for GxP-critical systems, ensuring compliance with PIC/S Annex 11 and 21 CFR Part 11. The role interfaces with IT, QA, and external partners to deliver validated software and documentation.

The ideal candidate has 3+ years' hands-on CSV validation experience in pharma/biotech, with a degree in CS/IT/engineering and strong communication and project-management skills.