Quality/Validation Engineer

The primary focus of this position is to actively lead all aspects of CSV activities in an FDA-regulated environment and ensure compliance with cGMP, 21 CFR Part 11, and ISO 13485 requirements. This is a multidisciplinary role & this individual will interface across many parts of the company (with scientists, researchers, and engineers) to develop and validate the best compliant solutions possible. The successful candidate should have direct experience in all activities in the Validation lifecycle and or Quality governance, guidance, and oversight in Pharmaceutical, Biotech, Medical Device, or combination. The candidate should be proficient on various types of testing during development and design to commissioning, FAT, and SAT to formal validation (IQ, OQ, PQ, UAT) in various testing environments (Development/Sandbox, Test/Validation, Production) as appropriate. The candidate should understand the system lifecycle from supplier evaluation, purchase, development, installation, testing, operation, maintenance, and then system retirement. The candidate should be detail-oriented and possess strong analytical and problem-solving skills. Having a medical device background is a plus. Responsibilities: * Working within a team of Quality Validation Engineers to support Quality, Facilities, Operations, QC, IT, Software, Mechanical, and Systems Engineering * Support, review, and approve documentation associated with qualification planning, intended use, user requirements, hazard analysis, risk assessments, functional and design specifications, design reviews, design V&V packages, test protocols, 21 CFR Part 11 compliance assessments, requirements trace matrix, Master Validation Plan and qualification report * For validation strategies and testing, perform independent reviews and apply knowledge of design, development, and testing of software during their entire system development life cycle, from the requirements gathering phase to the retirement phase * Develop, review, and or approve CSV protocols (IQ, OQ, PQ), coordinate execution of testing, and generation, review, and approval of validation reports * Ensure that cGMP and Change Control related CSV, and software systems are established, implemented, and maintained to ensure regulatory compliance, data integrity, and to optimize efficient and effective business processes * Act as an effective leader in supporting Software Quality Assurance (CSA) disciplines, decisions, and practices with coaching, and mentoring for Quality, Engineering, and other technical team personnel * Provide direction to project teams on software, CSV quality implementation processes and interpretation of procedural compliance requirements * Review and approve changes to existing systems, ensuring changes are implemented in compliance with internal procedures and external standards * Review test results for Good Documentation Practices (GDP) compliance and ensure that all test discrepancies to acceptance criteria are adequately controlled, documented, and addressed * Ensure the best quality practices are employed by all departments so that software/firmware based systems are developed, qualified, and maintained in a manner which provides assurance that the system conforms to both internal and external requirements * Author Standard Operating Procedures (SOPs) as required * Lead FUE or CSV related investigations and deviations generated during and post validation activities * As required, support audits, non-conforming events and CAPAs * Establish and promote an environment that supports the Quality Policy, cGMP, Data Integrity, and Quality Systems Requirements: * Bachelor's level degree or higher in Science, Engineering, or Software discipline * 5-7 years of related work experience in Validation or Quality for CSV, Automation, or Medical Device * Experience working in an FDA-regulated industry * Knowledge of System Development Life Cycles (SDLC) preferably with automated manufacturing and computerized lab systems * Knowledge of Validation Life Cycles (VLC) and applied experience in CSV, Automation, QC systems * Understanding of risk-based validation and data integrity requirements to perform assessments or apply applicable testing strategies * Practical knowledge of 21 CFR Part 11 (electron records/electronic signature), 21 CFR Parts 210, 211, GAMP 5, 21 CFR Part 820 and ISO 13485 * Experience in supporting manufacturing of medical devices desired * Must possess excellent organizational, clear verbal, and written communication skills * High level of attention to detail and compliance and ability to effectively support multiple high priority deliverables at once * Hands on approach, self-motivated with a passion for problem solving Job Type: Full-time Schedule: * 8 hour shift Ability to commute/relocate: * San Francisco Bay Area, CA: Reliably commute or planning to relocate before starting work (Required) Work Location: In person