Validation Engineer II

Artiva Biotherapeutics•San Diego, CA

21h•$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, 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.

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.
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.

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.
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.
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.