Validation Engineer I
ImmunityBio, Inc.
June 30, 2026
On-site
El Segundo, CA
Operations
Position Summary
The Validation Engineer I is responsible for generating and executing protocols, creating summary reports, and executing validation activities in FDA-regulated biopharmaceutical environments. Coordinates validation activities through constant communication with affected departments and personnel; supports senior staff on low-complexity projects.
Essential Functions
- Support collaboration with cross-functional departments, clients, CMOs, and vendors.
- Assist with validation activities for equipment, utility systems, facilities, processes, and automation systems in compliance with SOPs, cGMPs, and regulatory requirements.
- Generate/support/execute validation protocols (IQ/OQ/PQ/CV/PV) for site equipment (lab/production), utilities (as applicable), and related systems.
- Maintain inventory of GMP systems and requalification/periodic review schedules.
- Perform risk assessments for GMP systems.
- Plan validation efforts according to risk.
- Troubleshoot validation/qualification discrepancies; assist senior engineers with resolutions.
- Support validation team purchasing and oversee supplies/equipment inventory.
- Adhere to SOPs; support process improvements and template standardization.
- Perform ad-hoc/cross-functional duties and/or projects as assigned.
Basic Qualifications
- Bachelor’s degree in a science or related discipline (required).
- 1+ years validation or GMP-regulated industry experience (required).
- Facility commissioning and validation of equipment/facilities experience (required).
Preferred Qualifications
- Technical document writing/reviewing.
- Validation principles and industry standards.
- Commissioning and IQ/OQ/PQ knowledge for equipment/facilities.
- Quality systems knowledge: change control; CAPA (deviations/OOSs); training; document control.
- GMPs, OSHA compliance, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing, and plant equipment.
- Interpersonal, independent/teamwork, communication, and organizational skills.
Benefits (as stated)
- Medical, Dental, Vision Plan Options; Health and Financial Wellness Programs; EAP; Life/AD&D; Short/Long-Term Disability; Flexible Spending Accounts; 401(k) match; 529 Education Savings; Paid Time Off (11 holidays; unlimited PTO for exempt employees; vacation/health/personal/cultural day details for non-exempt).
Application Instructions
- Application window: anticipated to close 60 days from posting (or sooner if filled/closed).
The Validation Engineer I is responsible for generating and executing protocols, creating summary reports, and executing validation activities in FDA-regulated biopharmaceutical environments. Coordinates validation activities through constant communication with affected departments and personnel; supports senior staff on low-complexity projects.
Essential Functions
- Support collaboration with cross-functional departments, clients, CMOs, and vendors.
- Assist with validation activities for equipment, utility systems, facilities, processes, and automation systems in compliance with SOPs, cGMPs, and regulatory requirements.
- Generate/support/execute validation protocols (IQ/OQ/PQ/CV/PV) for site equipment (lab/production), utilities (as applicable), and related systems.
- Maintain inventory of GMP systems and requalification/periodic review schedules.
- Perform risk assessments for GMP systems.
- Plan validation efforts according to risk.
- Troubleshoot validation/qualification discrepancies; assist senior engineers with resolutions.
- Support validation team purchasing and oversee supplies/equipment inventory.
- Adhere to SOPs; support process improvements and template standardization.
- Perform ad-hoc/cross-functional duties and/or projects as assigned.
Basic Qualifications
- Bachelor’s degree in a science or related discipline (required).
- 1+ years validation or GMP-regulated industry experience (required).
- Facility commissioning and validation of equipment/facilities experience (required).
Preferred Qualifications
- Technical document writing/reviewing.
- Validation principles and industry standards.
- Commissioning and IQ/OQ/PQ knowledge for equipment/facilities.
- Quality systems knowledge: change control; CAPA (deviations/OOSs); training; document control.
- GMPs, OSHA compliance, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing, and plant equipment.
- Interpersonal, independent/teamwork, communication, and organizational skills.
Benefits (as stated)
- Medical, Dental, Vision Plan Options; Health and Financial Wellness Programs; EAP; Life/AD&D; Short/Long-Term Disability; Flexible Spending Accounts; 401(k) match; 529 Education Savings; Paid Time Off (11 holidays; unlimited PTO for exempt employees; vacation/health/personal/cultural day details for non-exempt).
Application Instructions
- Application window: anticipated to close 60 days from posting (or sooner if filled/closed).