Job Description

CSV Test Technician
Location: Oakville, Ontario
Job Type: 1-Month Contract
Compensation: $43.00 - $48.00/hour

Worklynx Recruitment Inc. is currently hiring a CSV Test Technician for one of our clients located in Oakville, Ontario. About the Role We are seeking a detail-oriented CSV Test Technician to support the development and production of innovative medical technology products. This hands-on role is responsible for executing validation and testing activities, troubleshooting issues, documenting results, and ensuring compliance with regulatory and quality standards. The successful candidate will work closely with Technical Owners, Engineering, and Quality teams to support computer system validation (CSV/CSA) activities across the system lifecycle. This is a short-term onsite contract opportunity ideal for candidates with experience in regulated environments and validation activities.

Key Responsibilities

• Design, develop, and execute test plans, protocols, and procedures
• Complete and maintain validation documentation, test results, and summary reports
• Support validation activities for electronic systems, applications, automated tools, custom scripts, and spreadsheets
• Assist with CSV/CSA deliverables throughout the validation lifecycle
• Ensure validation activities comply with applicable procedures, cGMP, GxP, and regulatory requirements
• Coordinate periodic reviews and audits related to system validation activities
• Support validation efforts for new system implementations and changes to existing systems
• Lead routine CSA lifecycle activities, including validation and audit coordination
• Author and review validation documentation including: o Validation Plans o Functional Risk Assessments o IQ/OQ/PQ protocols o Traceability Matrices o SOPs o Summary Reports
• Assist Technical Owners during testing activities and document test deviations or failures
• Support the development of system requirements and specifications for computerized systems used in regulated operation

Qualifications & Experience

• Experience with Computer System Validation (CSV) in regulated/GxP environments
• Strong understanding of engineering development systems and validation methodologies
• Familiarity with CSV documentation and validation lifecycle deliverables
• Knowledge of cGMP, GxP, GAMP, 21 CFR Part 11, and Good Documentation Practices
• Understanding of Quality Management System (QMS) processes including: o Design Control o Document Control o Change Control
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment
• Excellent attention to detail and problem-solving abilities
• Strong written and verbal communication skills

Hiring Process Disclosure Applications will be reviewed as part of our recruitment and selection process. Artificial intelligence (AI) tools will not be used to screen, assess, or select applicants for this position. All applications will be reviewed by a member of our recruitment team. By applying, you agree to be added to our talent pool and may be contacted for a general screening as new positions arise.

Equal Opportunity & Accessibility Worklynx Recruitment Inc. and our clients are committed to providing equal employment opportunities in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act (AODA). Accommodations are available upon request throughout the recruitment process.

Company Description Worklynx Recruitment Inc. partners with employers to place skilled talent in contract and permanent roles across Ontario. This job posting is for a current vacancy with our client.