CSA/CSV Test Technician

Vitalbio; Oakville; On-site; CAD 55,000 - 85,000; Full time

Job summary

Vitalbio is looking for a meticulous Test Technician to support medical device development and production. In this role, you'll conduct tests, troubleshoot, and ensure compliance with industry standards. You will work closely with technical teams to document and manage validation processes. Join us to make a meaningful impact in healthcare!

Benefits

Competitive compensation package

Opportunity to impact medical diagnostics

Collaborative team environment

Qualifications

• Experience in leading and executing validation activities for GxP electronic systems.
• Knowledge of cGMP, GxP, GAMP standards.
• Strong understanding of QMS processes.

Responsibilities

• Design, develop, and execute test plans and protocols.
• Complete documentation for test results.
• Coordinate system validation activities and audits.

Skills

Attention to detail

Testing procedures

Troubleshooting

Education

Experience in Computer Systems Validation

Job description

About you:

We are seeking a meticulous Test Technician to join our team and support the development and production of our innovative medical device. In this hands-on role, you will be responsible for conducting detailed tests, troubleshooting issues, and analyzing results to ensure the quality and safety of our products. Your strong attention to detail will be critical in identifying potential issues and maintaining compliance with industry standards. If you are passionate about precision, healthcare innovation, and making a difference, we invite you to apply to be a part of our mission.

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;

• 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 bring:

• 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.

What you’ll get:

• An opportunity to change the face of medical diagnostics

• Working with a high-functioning, deeply motivated team

• A competitive compensation package

• An environment where one can showcase one's talent and know that his/her contributions, thoughts, ideas, and expertise are valued every day

About Vital

Vital is revolutionizing point-of-care diagnostics with our VitalOne platform, delivering real-time care wherever patients are. Our mission is to democratize health technology, making healthcare more accessible and proactive.

Our global team of experts spans chemistry, software, engineering, and microfluidics. We thrive on change, operate on trust, and value diverse perspectives. Our growth-minded culture empowers front-line decision-making and fosters impactful work.

We seek tenacious, bold individuals ready to transform healthcare. At Vital, your talent will make a difference as we work to ensure everyone has access to care when and where they need it.

Vital Biosciences Inc. is an equal opportunity employer and values diversity in the workplace. We are therefore happy to accommodate any individual needs in keeping with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. If you require accommodation in order to participate in our hiring process, please contact us to make your needs known in advance.