JSat Automation is hiring a Permanent Verification and Validation Engineer in their Oakland, CA office that will work in the Laboratory Operations group and collaborate across functions (e.g. quality, IT, and vendors) and assist Device Engineers and Laboratory staff in developing practical and thorough solutions to problems, and execute validation activities: method validation, equipment qualification, computer system validation, and method transfer.
This objective will be accomplished by executing the following activities:
- Coordinate and execute commissioning and qualification of laboratory equipment and computer systems (e.g. hardware, software, and accessory systems) for use in regulated and non-regulated operations.
- Author/ review commissioning and qualification documents throughout system life cycle. This includes deliverables such as user requirements, functional/design specifications, qualification protocol/report, and support documentation (i.e. traceability matrices, SOP, etc.).
- Author/ review validation and verification protocols documents to support device development deliverables such as protocols/ reports, test methods, and risk assessments.
- Execute/ lead test method validation, design verification, and method transfer as required by the lab/projects.
- Develop/review/ validate physical test methods to support the selection, design verification, commercialization and marketing of various new combination devices.
- Design test fixtures and perform First Article Inspections.
- Support procurement and installation activities when needed to ensure proper systems startup and recommend changes to improve system design.
- Execute characterization testing to support the selection, design verification, commercialization and marketing of various designs.
- Regularly interact with external development partners and equipment suppliers, Quality, and IT group.
- Knowledge of FDA regulations and knowledge of 21 CFR Part 11.
- Experience in developing and building (test) fixtures, drawing, and CAD/ SolidWorks.
- Knowledge/experience of qualification requirements and procedures for laboratory instrumentation.
- Knowledge of Measurement System Analysis (MSA) and statistical data analysis
- Working knowledge of the development of protocols for validation of instruments.
- Knowledge of Design Controls for regulatory compliance & filing (ISO 13485, etc.), GDP/GLP/GMP, Design History Files, Risk Assessments, etc.
- Excellent oral and written communication skills