Canon BioMedical, Inc. is dedicated to extending innovative Canon core technologies into the burgeoning life sciences field — and to the introduction and marketing of vital, new-platform products in the critical area of molecular diagnostics.
Canon BioMedical is currently seeking a Sr. Validation Engineer reporting into the Manager, Quality Engineering & Validation. With direction from the Manager, Quality Engineering & Validation, the Sr. Validation Engineer will a be key resource to facilitate the development and implementation of the Validation Program in the planning, scheduling, and execution of validation projects such as manufacturing and QC equipment, computer systems validation, medical device software validation, facility, utility and analytical assay validations as well as design verification activities for new product development activities. The successful candidate will help develop validation strategies and facilitate compliance during product development cycles and commercialization of new products that are consistent with validation policies and procedures, as well as internal, and external requirements. Individual will be responsible for developing and coordinating a company wide metrology program. Ensures compliance with applicable medical device regulations (FDA, EU, Health Canada, ISO 13485).
- Develop strategies for, and schedule, plan, author, and execute as needed verification and validation test protocols and reports to support product commercialization and manufacturing of an automated genetic analyzer for In Vitro Diagnostic (IVD) use (hardware, software, assay chemistry) according to schedule.
- Review and prepare for approval, validation project documentation.
- Interface with R&D (Assay and Instrument), Engineering, Software Development, IT, Manufacturing and Quality Assurance groups to support the validation activities that will assure successful project execution.
- Provide Quality input for validation deviation investigations to resolve execution or result discrepancies and participate in the resolution of deviations and corrective/preventive actions.
- Provide Quality review and assessment of associated change requests related to processes, equipment, material, facilities, software, and computer systems.
- Analyze and report trends in manufacturing and quality.
- Support development of best demonstrated validation practices in the validation department, based on current industry practices and guidelines and in accordance with appropriate regulatory agency validation requirements (GAMP, FDA, GHTF, ISO, IEC, EU, Health Canada).
- Use statistical techniques, sampling plans, DOE, Gage R&R and other quality engineering tools as needed in performing job duties.
- Author assigned Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidance to ensure compliance with Company policies and federal regulations.
- May help oversee software development life cycle (SDLC) for medical device software to ensure compliance with IEC62304.
- Contribute to the evaluation of software and computer systems vendors for Part 11 compliance, audits existing systems, and addresses validation gaps and needs.
- Provide computer systems validation support and guidance for electronic quality management systems, spreadsheets, databases and other systems subject to 21CFR Part 11 requirements.
- Support the management of equipment calibration program to include oversight of outsourced calibration activities, scheduling, and validation of equipment and systems where applicable.
- Participate in risk analysis activities including using risk based approach in design of validation protocols.
- Provide training and guidance to other departments concerning validation requirements and protocol execution.
- Perform other duties as assigned by the Manager, Quality Engineering & Validation.