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Artiva Biotherapeutics, a clinical-stage biotechnology company developing natural killer (NK) cell-based therapies for autoimmune diseases, is seeking a Validation Engineer II to support qualification and validation activities for GMP facilities, utilities, equipment, computerized systems, and manufacturing processes supporting cell therapy manufacturing operations.
The successful candidate will support lifecycle validation activities while ensuring compliance with FDA, EU GMP, and internal quality requirements. This is a hands-on role requiring on-the-floor presence in classified manufacturing space and direct collaboration with manufacturing, facilities, engineering, quality, and regulatory teams.
Key Responsibilities:
Validation, Qualification, and Lifecycle Management: Author, execute, review, and approve IQ, OQ, PQ protocols and validation reports. Author change controls, system impact assessments, user requirement specifications, design qualifications, and requirements traceability matrices. Review vendor-supplied qualification protocols before execution to identify gaps. Document, investigate, and resolve discrepancies and test exceptions during protocol execution. Perform thermal mapping and requalification of controlled temperature units using wireless data loggers. Support commissioning, qualification, startup, field verification, and testing activities for GMP manufacturing systems, utilities, facilities, and equipment. Manage validation vendor and service provider relationships — schedule activities, oversee execution, technically review documentation for cGMP compliance, and drive projects to completion. Maintain validation lifecycle documentation, status tracking, periodic review, and requalification schedules in coordination with Quality, Calibration, Facilities, and Manufacturing.
Risk, Quality Events, and Compliance: Perform risk assessments, FMEA, system impact assessments, and component criticality determinations per ICH Q9 and ASTM E2500. Own validation-related deviations, investigations, root cause analysis, and CAPAs. Evaluate quality events, maintenance activities, and proposed changes for impact to validated state. Ensure compliance with FDA cGMP (21 CFR 210/211), EU GMP Annex 1, Annex 11, and Annex 15, ASTM E2500, ISPE/GAMP guidance, and internal quality systems. Support regulatory inspections, client audits, and internal audits.
Cross-Functional Support: Partner with Manufacturing, Facilities, Engineering, Quality, Automation, and Regulatory Affairs on equipment onboarding, facility expansion, technology transfer, and capital projects. Support equipment onboarding end to end: specification and vendor quote review, factory and site acceptance testing, installation coordination, asset record creation, and handoff to end users. Coordinate qualification activities around manufacturing schedules to minimize production impact. Provide on-the-floor support during execution — gowning into classified manufacturing space, coordinating site access for vendor field service engineers, and troubleshooting alongside Manufacturing and Facilities. Support user training and turnover activities. Communicate validation status, risks, and open items clearly to stakeholders. Work independently on assigned tasks with general direction, escalating technical and compliance questions to senior validation staff as needed. Adapt to shifting priorities and support off-shift, weekend, or extended-hours execution when required.
Requirements:
Education and Experience:
• Bachelor's degree in Engineering, Biotechnology, Life Sciences, Chemistry, or a related technical discipline
• 2–5 years of validation experience in a regulated GMP environment
• Experience authoring and executing qualification protocols, validation reports, and lifecycle documentation
• Working knowledge of equipment, utility, facility, process, and risk-based validation principles, including ICH Q9 and ASTM E2500
• Experience performing thermal mapping or thermal validation studies using wireless data loggers and associated software
• Experience authoring or supporting change controls, deviations, investigations, and CAPAs within a formal quality management system
• Working knowledge of FDA cGMP requirements (21 CFR 210/211) and good documentation practices
• Ability to gown and work in classified manufacturing space, and to support execution activities on the manufacturing floor
Preferred Qualifications:
• Experience supporting cell therapy, gene therapy, biologics, sterile manufacturing, aseptic processing, or controlled environments
• Knowledge of EU GMP Annex 1, Annex 15, ASTM E2500, ISPE guidance, 21 CFR Part 11, CSV/CSA, and contamination control strategies
• Experience qualifying cleanrooms, HVAC, environmental monitoring systems, cryogenic storage, controlled-rate freezers, biosafety cabinets, incubators, or similar GMP systems
• Experience maintaining asset and qualification records in a CMMS or asset management system (e.g., Blue Mountain RAM or equivalent)
• Experience coordinating validation vendors and field service engineers, including protocol review and scheduling
• Experience supporting facility startup, expansion, technology transfer, regulatory inspections, or client audits in a startup or growth-stage biotechnology organization
Key Competencies:
• GMP validation lifecycle knowledge, technical writing, and inspection-ready documentation practices
• Risk-based problem solving, contamination control awareness, and continuous improvement mindset
• Strong collaboration, organization, and project execution skills in a fast-paced environment
Additional Information: Full-time position based in a GMP-regulated facility in San Diego, CA. Occasional off-shift, weekend, or extended-hours work required to support manufacturing schedules and vendor field service availability. On-call activities required as assigned. Reports to Sr. Manager, Validation, Calibration and Engineering.
