Validation Engineer II

About Artiva:
We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs).

We believe the compelling cell-killing properties of NK cells, when combined with mAbs for targeting, create an opportunity to generate potentially transformative therapies.

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Make an impact. Help shape the future of cell therapy. Join Artiva’s Validation team and take hands‑on ownership of critical GMP qualification activities while building your expertise in a dynamic, growing biotech.

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.

• Author, execute, review, and approve IQ, OQ, PQ protocols and validation reports, ensuring deliverables are technically sound, compliant, and inspection‑ready.
• Author change controls for new equipment, system impact assessments, user requirement specifications, design qualifications, requirements traceability matrices, and other qualification deliverables as needed.
• Review vendor‑supplied qualification protocols before execution to identify gaps and resolve them with the vendor before work begins.
• Document, investigate, and resolve discrepancies and test exceptions encountered during protocol execution; elevate to deviation or change control as appropriate.
• Perform thermal mapping and requalification of controlled temperature units using wireless data loggers and associated software, including study design, data analysis, and final report authoring.
• 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 qualification activities, oversee execution, technically review vendor‑supplied documentation for cGMP compliance, and drive project work to completion.
• Maintain validation lifecycle documentation — status tracking, periodic review, and requalification schedules — and partner with Quality, Calibration, Facilities, and Manufacturing to ensure the asset management system reflects the current qualification, calibration, and maintenance state of every GMP instrument on campus

• Perform risk assessments, FMEA, system impact assessments, and component criticality determinations per ICH Q9 and ASTM E2500 to define qualification scope and justify leveraging vendor documentation where appropriate.
• Own validation‑related deviations, investigations, root cause analysis, and CAPAs, driving quality events to timely closure.
• Evaluate quality events, maintenance activities, and proposed changes for impact to validated state, and determine whether requalification or revalidation is warranted.
• Ensure compliance with FDA cGMP (21 CFR 210/211), EU…