Validation Engineer II

Artiva Biotherapeutics•San Diego, CA

1d•$87,000 - $103,000•Onsite

About The Position

Artiva Biotherapeutics 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. Experience in cell therapy, biologics, aseptic manufacturing, Annex 1 contamination control, and startup or high-growth biotechnology environments is preferred.

Requirements

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.

Nice To Haves

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 supporting facility startup, expansion, technology transfer, regulatory inspections, or client audits in a startup or growth-stage biotechnology organization.

Responsibilities

Author, execute, review, and approve IQ, OQ, IOQ, IOPQ, PQ, requalification protocols, and validation reports.
Support commissioning, qualification, startup, field verification, and testing activities for GMP manufacturing systems, utilities, facilities, and equipment.
Maintain validation lifecycle documentation and ensure deliverables are technically sound, compliant, and inspection-ready.
Assess change controls, system impacts, validation requirements, and ongoing compliance needs.
Perform risk assessments, FMEA, impact assessments, and criticality determinations using risk-based validation and ASTM E2500 principles.
Support validation-related deviations, investigations, root cause analysis, CAPAs, and timely closure of quality events.
Ensure compliance with FDA cGMP, EU GMP Annex 1 and Annex 15, ASTM E2500, ISPE guidance, and internal quality systems.
Support regulatory inspections, client audits, and internal audits.
Partner with Manufacturing, Facilities, Engineering, Quality, Automation, and Regulatory Affairs to support equipment onboarding, facility expansion, technology transfer, capital projects, and project execution.