Cell Therapy GMP Validation Engineer II

Artiva Biotherapeutics Inc.; San Diego (CA); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Medical, Dental, and Vision

401(k) Retirement Plan

Paid Time Off

Job summary

Artiva Biotherapeutics Inc. in San Diego, CA, seeks a Validation Engineer II to lead qualification and validation activities across GMP facilities, utilities, equipment, and manufacturing processes supporting cell therapy operations.

The role emphasizes lifecycle validation, FDA and EU GMP compliance, and collaboration with Manufacturing, Quality, and Regulatory Affairs to ensure inspection-ready validation documents.

Qualifications

• Bachelor's degree in Engineering, Biotechnology, Life Sciences, Chemistry or related field.
• 2–5 years of validation experience in a regulated GMP environment.
• Experience authoring and executing qualification protocols, validation reports, and lifecycle documentation.

Responsibilities

• Author, execute, review, and approve IQ, OQ, PQ protocols and validation reports.
• Draft change controls, user requirements, design qualifications, and traceability matrices.
• Review vendor qualification protocols and resolve gaps before execution.
• Perform thermal mapping and requalification of controlled temperature units with wireless data loggers.
• Support commissioning, qualification, startup, field verification, and testing for GMP systems, facilities, and equipment.
• Manage validation vendors and service provider relationships, schedules, and documentation.
• Maintain lifecycle documentation, status tracking, and requalification plans.

Skills

IQ/OQ/PQ protocols

Change controls

Vendor management

Risk assessment

GMP knowledge

Education

Bachelor's degree in Engineering, Biotechnology, Life Sciences, Chemistry

Job description

Artiva Biotherapeutics Inc. in San Diego, CA, seeks a Validation Engineer II to lead qualification and validation activities across GMP facilities, utilities, equipment, and manufacturing processes supporting cell therapy operations.

The role emphasizes lifecycle validation, FDA and EU GMP compliance, and collaboration with Manufacturing, Quality, and Regulatory Affairs to ensure inspection-ready validation documents.