CSV Test Technician
Vital Bio
Mississauga, ON, Canada
Posted on Nov 24, 2024
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
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 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.
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