Validation Engineer II at Artiva Biotherapeutics in San Diego, California

Job description

• 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.

Responsibilities

• · 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; escalate 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
• Risk, Quality Events, and Compliance
• · 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 GMP Annex 1, Annex 11, and Annex 15, ASTM E2500, ISPE/GAMP guidance, and internal quality systems; assess gaps against new or revised regulatory expectations and drive remediation.
• · Support regulatory inspections, client audits, and internal audits — including front- and back-room support, retrieval of validation records, and authoring responses to observations and findings.
• Cross-Functional Support
• · Partner with Manufacturing, Facilities, Engineering, Quality, Automation, and Regulatory Affairs on equipment onboarding, facility expansion, technology transfer, and capital projects — representing Validation in project team meetings, design reviews, and capital planning so qualification scope and timelines shape projects rather than react to them.
• · 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 and campaign windows to minimize impact to production, and escalate schedule risk early.
• · Provide on-the-floor support during execution — gowning into classified manufacturing space, coordinating site access for and escorting vendor field service engineers, and troubleshooting alongside Manufacturing and Facilities. Execution work happens where the equipment is, not at a desk.
• · Support user training and turnover activities so systems transfer cleanly into routine GMP use with current SOPs and documentation.
• · Communicate validation status, risks, and open items clearly to stakeholders at all levels, and follow up persistently across departments and vendors — much of the work is tracking commitments to closure and chasing information that isn't volunteered.
• · 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 — qualification schedules move with vendor availability, equipment readiness, and production needs, and rework of executed documentation is a normal part of the job.

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.
• · 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.
• · 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.
• · 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.

Skills

Required

• Good documentation practices
• Risk-based problem solving
• Contamination control awareness
• Continuous improvement mindset

Benefits

• · A beautiful facility
• · An entrepreneurial, highly collaborative, and innovative environment
• · Medical, Dental, and Vision
• · Group Life Insurance
• · Long-Term Disability (LTD)
• · 401(k) Retirement Plan
• · Employee Assistance Program (EAP)
• · Flexible Spending Account (FSA)
• · Paid Time Off (PTO)
• · Company-paid holidays, including the year-end holiday week
• · Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
• $87,000 - $103,000