Validation Verification Scientist is responsible for planning, implementing and monitoring the validation strategy and planning in the reagent manufacturing environment. You will measure and analyze the process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result to ensure the highest quality products are produced.
Position Responsibilities/Essential Functions
- Responsible for planning and executing Product Validation testing and reporting. This includes designing, writing, and executing test protocols and documenting results.
- Design, execute, and document experiments to assess the effects of instrumentation performance on biochemical reagents.
- Design, execute, and document equipment IQ/OQ/PQ and preventative maintenance procedures for production, end-users and service personnel.
- Contribute to product designs to ensure compliance with functional and technical specifications.
- Conducting troubleshooting and failure analysis as required – both independently and with strong support from Fluidigm production and R&D.
- Participate in and contribute to product Risk Management activities including FTA and FMEA.
- Experience designing, conducting and documenting verification activities for clinical laboratory instrumentation.
- Experience designing and conducting product validation or similar tests for clinical laboratory equipment to ensure equipment meets required performance specifications.
- Understanding of regulated quality systems (e.g. ISO 13485, 21 CFR 820, ISO 14971, ISO 60812) and applicable product safety standards such as IEC 61010 and IEC 61326.
- Excellent written and oral communication skills and a proven ability to work well on a multi-disciplinary team.
- Demonstrated proficiency utilizing statistical techniques for characterizing, troubleshooting, and optimizing clinical in-vitro diagnostics devices.
- Knowledge of usage, repair, storage, calibration of monitoring devices, and other instrumentation.
Minimum Job Requirements:
- BS in Chemistry/Biochemistry or related discipline with at least 5 years related industry experience (cytometry preferred)
- A minimum of 3 years of quality/process validation and project management experience in a pharmaceutical / medical device or in vitro diagnostic environment.
- Strong knowledge of MS Word and Excel
- Strong communication and organizational skills
- Proven ability to multitask, set and manage priorities based on organization requirements
The Company is committed to providing an inclusive and barrier free recruitment process to applicants with accessibility needs in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act (AODA). If you require an accommodation during this process, please inform The Company of your requirements. We are an equal opportunity employer.