Csv Test Technician

1 month ago


Mississauga, Canada Vital Biosciences Inc. Full time

Vital is revolutionizing the landscape of point-of-care diagnostics with our groundbreaking platform, VitalOne, designed to deliver real-time care wherever patients are. Over the past five years, we have built a dynamic team of over 100 experts across various disciplines including chemistry, software, engineering, and microfluidics to fulfill our mission of making healthcare more accessible and proactive. At Vital, we seek tenacious, bold, and enthusiastic individuals ready to create impactful change in the healthcare industry.

**The role**

**What you’ll do**:

- Design, develop, and execute test plans, protocols, and procedures;
- Complete documentation for test results and reports;
- 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**:

- 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



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