Validation Engineer (1-3 years of experience)

JSat Automation is hiring a Permanent Verification and Validation Engineer in their Oakland, CA office that willwork in the Laboratory Operations group and collaborate across functions (e.g.quality, IT, and vendors) and assist Device Engineers and Laboratory staff indeveloping practical and thorough solutions to problems, and execute validationactivities: method validation, equipment qualification, computer systemvalidation, and method transfer.

This objective will be accomplished byexecuting the following activities:

·Coordinate and execute commissioning and qualification of laboratoryequipment and computer systems (e.g. hardware, software, and accessory systems)for use in regulated and non-regulated operations.

·Author/ review commissioning and qualification documents throughoutsystem life cycle. This includes deliverables such as user requirements,functional/design specifications, qualification protocol/report, and supportdocumentation (i.e. traceability matrices, SOP, etc.).

·Author/ review validation and verification protocols documents tosupport device development deliverables such as protocols/ reports, testmethods, and risk assessments.

·Execute/ lead test method validation, design verification, and methodtransfer as required by the lab/projects.

·Develop/review/ validate physical test methods to support the selection,design verification, commercialization and marketing of various new combinationdevices.

·Design test fixtures and perform First Article Inspections.

·Support procurement and installation activities when needed to ensureproper systems startup and recommend changes to improve system design.

·Execute characterization testing to support the selection, designverification, commercialization and marketing of various designs.

·Regularly interact with external development partners and equipmentsuppliers, Quality, and IT group.

Requirements

·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 forlaboratory 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 (ISO13485, etc.), GDP/GLP/GMP, Design History Files, Risk Assessments, etc.

·Excellent oral and written communication skills