Validation Engineer II

We need to output HTML fragment with sections: About the role? Actually the posting includes "About Artiva" description, then "Position Summary", "Essential Responsibilities", "Qualifications", "Key Competencies", "Additional Information". We need to use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. But we must only include sections when posting has real specific content. The posting includes: About Artiva (company description) maybe not "About the role". The "Position Summary" could be considered "About the role". We'll map accordingly. We need to avoid repeating job title as heading. No Job ID. We need to use

• for any list of duties/requirements/benefits. Use

  for prose. We must preserve all substantive info, not invent or summarize away detail. Remove boilerplate like EEO etc (none). Remove duplicated lines. We need to decide sections: - About the role: could contain Position Summary paragraph. - Responsibilities: Essential Responsibilities (list of duties). Could be broken into subcategories but we can just list as

  • each bullet. - Requirements: Qualifications (Education and Experience) plus maybe Preferred Qualifications? Could combine. - Skills: Key Competencies. - Benefits: Additional Information includes benefits list. - Pay: Not mentioned, so omit. - Schedule: Additional Information mentions occasional off-shift, weekend, extended-hours work required; on-call activities required as assigned. That's schedule info. So we can include Schedule section. We must not create sections with filler like "commensurate with experience". Not present. We need to ensure we don't repeat content unnecessarily. Let's extract content. About Artiva paragraph: "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. For more information, visit www.artivabio.com 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." That's a bit long but we keep. Position Summary: "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." We could combine About Artiva and Position Summary under About the role? Might be redundant but okay. Better: About the role: Position Summary paragraph. But we also have company description; maybe we can include that as part of About the role as well. The instruction: "Use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So we can have About the role section containing both company overview and position summary. That's fine. Responsibilities: list each essential responsibility bullet. Let's extract bullet points from "Essential Responsibilities:" section. The text after that heading includes paragraphs with semicolons. We need to break into list items. We'll parse each sentence that starts with a verb. List: - 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. Then "Risk, Quality Events, and Compliance" subsection: we could include as part of Responsibilities as well. List: - 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. Then "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. - 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. That's many items; we can keep them as list. Now Requirements: Qualifications section includes Education and Experience bullet list. Extract: - 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 (could be part of Requirements or separate; but we have Requirements heading; we can include both required and preferred under Requirements, maybe separate subheadings? But we only allowed headings list; we could still include preferred as part of Requirements section as list items, maybe label them? But we must not invent headings not allowed. We can just include them as list items; it's okay. Preferred qualifications list: - 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. Now Skills: Key Competencies bullet list. Extract: - 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. Now Benefits: Additional Information includes benefits list. Extract: - A beautiful facility - An entrepreneurial, highly collaborative, and innovative environment - Comprehensive benefits, including: - 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. We need to format as list. Now Schedule: Additional Information includes: - 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. We can include schedule info: occasional off-shift, weekend, extended-hours; on-call activities. Now we must not include Pay section. Now produce HTML fragment. We'll wrap each section in

    heading then content. For lists, use

    • ...

    . For prose, use

    . We need to ensure we don't duplicate content. Let's craft. About the role: include company description and position summary as paragraphs maybe combined. We'll do:

    About the role

    [company description + position summary]

    We need to ensure we don't repeat sentences. Company description: "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).