Validation Engineer II

artivabio; San Diego (CA); On-site; USD 87,000 - 103,000; Full time

Benefits offered by this job

Medical, Dental, and Vision

401(k) Retirement Plan

Paid Time Off (PTO)

Company paid holidays

Job summary

artivabio is looking for a Validation Engineer II in San Diego, California, to support qualification and validation activities for GMP facilities. You will ensure compliance with FDA and internal quality requirements while assisting with lifecycle validation activities.

The ideal candidate will have 2–5 years of experience in a regulated GMP environment and a Bachelor's degree in a related field. This full-time role includes a competitive salary and comprehensive benefits.

Qualifications

• 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.

Responsibilities

• Author, execute, review, and approve validation protocols and reports.
• Support commissioning and qualification for GMP manufacturing systems.
• Perform risk assessments and ensure compliance with FDA cGMP.

Skills

GMP validation lifecycle knowledge

Technical writing

Risk-based problem solving

Collaboration skills

Project execution skills

Education

Bachelor's degree in Engineering, Biotechnology, Life Sciences, Chemistry, or a related technical discipline

Job description

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.

Essential 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.

Risk, Quality Events, and Compliance

• 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.

Cross‑Functional Support

• Partner with Manufacturing, Facilities, Engineering, Quality, Automation, and Regulatory Affairs to support equipment onboarding, facility expansion, technology transfer, capital projects, and project execution.

Qualifications

• Education: 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.

Preferred Qualifications

• 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.

Key Competencies

• 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.

Additional Information

• Full‑time, Monday‑Friday position based in a GMP‑regulated facility in San Diego, CA.
• On‑call activities required as assigned.
• Reports to Validation Lead.

In addition to a great culture, we offer:

• 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
• A recognition program where points earned can be traded for items you want.

If all this speaks to you, come join us on our journey!

Base salary: $87,000–$103,000 annually. Exact compensation may vary based on level, skills and experience.