Validation Engineer I
ImmunityBio, Inc.
August 26, 2026
On-site
El Segundo, CA
Operations
Position Summary
The Validation Engineer I generates and executes protocols, creates summary reports, and performs validation activities in FDA-regulated biopharmaceutical environments. Coordinates validation activities through communication with affected departments; works on projects of minimal complexity in a support role with senior staff.
Essential Functions
- Support collaboration with cross-functional departments, clients, CMOs, and vendors.
- Assist with validation of equipment, utility systems, facilities, processes, and automation systems per SOPs, cGMPs, and regulatory requirements.
- Generate, support, and execute validation protocols (IQ/OQ/PQ/CV/PV) for site equipment (including lab/production equipment), utilities (as applicable), and related systems.
- Maintain GMP systems inventory and requalification/periodic review schedules.
- Perform risk assessments for GMP systems; plan validation efforts according to risk.
- Troubleshoot validation/qualification discrepancies and assist senior engineers with resolutions.
- Support validation team purchasing and oversee supplies/equipment inventory as needed.
- Adhere to SOPs; support process improvements and template standardization.
- Perform ad-hoc/cross-functional duties to support business needs.
Basic Qualifications
- Bachelor’s degree in a science or related discipline.
- 1+ years validation or GMP-regulated industry experience.
- Experience with facility commissioning and validation of equipment/facilities.
Preferred Qualifications
- Technical document writing/review.
- Validation principles/industry standards; commissioning and IQ/OQ/PQ (equipment/facilities).
- Quality systems knowledge: change control; CAPA (deviations/OOS); training and document control.
- GMPs, OSHA, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing, plant equipment.
- Interpersonal, independent and team work; communication and organizational skills.
Benefits
- Eligible for discretionary bonus and equity award.
Application Instructions
- Application window: anticipated to close 60 days from posting or sooner if filled/closed.
The Validation Engineer I generates and executes protocols, creates summary reports, and performs validation activities in FDA-regulated biopharmaceutical environments. Coordinates validation activities through communication with affected departments; works on projects of minimal complexity in a support role with senior staff.
Essential Functions
- Support collaboration with cross-functional departments, clients, CMOs, and vendors.
- Assist with validation of equipment, utility systems, facilities, processes, and automation systems per SOPs, cGMPs, and regulatory requirements.
- Generate, support, and execute validation protocols (IQ/OQ/PQ/CV/PV) for site equipment (including lab/production equipment), utilities (as applicable), and related systems.
- Maintain GMP systems inventory and requalification/periodic review schedules.
- Perform risk assessments for GMP systems; plan validation efforts according to risk.
- Troubleshoot validation/qualification discrepancies and assist senior engineers with resolutions.
- Support validation team purchasing and oversee supplies/equipment inventory as needed.
- Adhere to SOPs; support process improvements and template standardization.
- Perform ad-hoc/cross-functional duties to support business needs.
Basic Qualifications
- Bachelor’s degree in a science or related discipline.
- 1+ years validation or GMP-regulated industry experience.
- Experience with facility commissioning and validation of equipment/facilities.
Preferred Qualifications
- Technical document writing/review.
- Validation principles/industry standards; commissioning and IQ/OQ/PQ (equipment/facilities).
- Quality systems knowledge: change control; CAPA (deviations/OOS); training and document control.
- GMPs, OSHA, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing, plant equipment.
- Interpersonal, independent and team work; communication and organizational skills.
Benefits
- Eligible for discretionary bonus and equity award.
Application Instructions
- Application window: anticipated to close 60 days from posting or sooner if filled/closed.