CSV Test Technician (1- Month Contract)
Job Description
CSV Test Technician (1- Month Contract)
Department: Quality
Employment Type: Contract / Temp
Location: Oakville, Ontario HQ
Reporting To: Nigel Dewsbury
Compensation: $43.00 - $48.00 / hour
Description
About you:
What you’ll do:
- Design, develop, and execute test plans, protocols, and procedures;
- Complete documentation for test results and reports;
- Partner with Technical Owners and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle;
- Execute and support validation activities for custom scripts, automated tools, spreadsheets, and software systems in accordance with CSV/CSA procedures and applicable regulatory requirements.
- Ensure that routine tasks supporting the validation of electronic systems and applications are documented following the relevant procedures and regulations;
- Coordinate periodic reviews and audits of system validation activities;
- Support computer system validation efforts for new system implementations and changes to existing systems;
- Lead routine CSA lifecycle activities (system validation and audits), coordinating with system owners and Quality following company procedures and regulatory requirements;
- Author and review applicable CSA documentation such as validation plans, test protocols, functional risk assessments, qualification procedures, admin and end-user SOPs;
- Assist Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures;
- Assist Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
What You’ll Need:
- Experience in Computer Systems Validation (CSV) - working cross-functionally to lead and execute validation activities for GxP electronic systems and applications;
- Strong knowledge of Engineering development systems;
- Familiarity with the development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ/OQ/PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.);
- Knowledge of cGMP, GxP, GAMP, including 21 CFR Part 11, and good documentation practices;
- A strategic understanding of how to develop business/system requirements to efficiently guide key testing activities
- Strong understanding of key QMS processes like Design Control, Document Control, Change Control, etc.
- Ability to work effectively in a fast-paced environment and manage multiple priorities.
Why Join Us?
- Help ensure our systems are validated with the rigor needed to support innovative medical diagnostics.
- You’ll work closely with Technical Owners and Quality on meaningful validation work, gain exposure to GxP and CSV activities across the product lifecycle, and contribute to a team that values precision, collaboration, and the impact of your work.