Validation Engineer I
ImmunityBio, Inc.
September 01, 2026
On-site
El Segundo, CA
Operations
Position Summary
The Validation Engineer I generates and executes validation protocols, creates summary reports, and performs validation activities in FDA-regulated biopharmaceutical environments. Coordinates validation activities through communication with affected departments and works closely with senior staff.
Essential Functions
- Collaborate with cross-functional departments, clients, CMOs, and vendors.
- Assist with validation of equipment, utilities, 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 systems in an FDA-regulated environment.
- Maintain current inventory of GMP systems and requalification/periodic review schedules.
- Perform risk assessments and plan validation efforts according to risk.
- Troubleshoot discrepancies during validation/qualification; assist senior engineers with resolutions.
- Support validation team purchasing and oversee supplies/equipment inventory as needed.
- Adhere to SOPs, process improvements, and template standardization.
- Perform ad-hoc/cross-functional duties supporting 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/reviewing.
- Validation principles/practices and industry standards.
- Working knowledge of commissioning and IQ/OQ/PQs.
- Quality systems: change control; CAPA (deviations/OOSs); training; document control.
- GMPs, OSHA compliance, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing/plant equipment.
- Strong interpersonal, independent and team collaboration, communication, and organization.
Working Environment / Physical Environment
- On-site; exposure to in-lab environment; use required PPE.
- Lift/carry: frequently up to 35 lbs; occasionally up to 50 lbs.
Compensation/Benefits (as stated)
- Discretionary bonus and equity award.
- Base pay range: $88,200–$98,000 annually.
- Eligible benefits include medical/dental/vision; wellness programs; EAP; life/AD&D and disability; FSA; 401(k) match; 529; PTO (11 holidays) and other PTO details.
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).
The Validation Engineer I generates and executes validation protocols, creates summary reports, and performs validation activities in FDA-regulated biopharmaceutical environments. Coordinates validation activities through communication with affected departments and works closely with senior staff.
Essential Functions
- Collaborate with cross-functional departments, clients, CMOs, and vendors.
- Assist with validation of equipment, utilities, 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 systems in an FDA-regulated environment.
- Maintain current inventory of GMP systems and requalification/periodic review schedules.
- Perform risk assessments and plan validation efforts according to risk.
- Troubleshoot discrepancies during validation/qualification; assist senior engineers with resolutions.
- Support validation team purchasing and oversee supplies/equipment inventory as needed.
- Adhere to SOPs, process improvements, and template standardization.
- Perform ad-hoc/cross-functional duties supporting 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/reviewing.
- Validation principles/practices and industry standards.
- Working knowledge of commissioning and IQ/OQ/PQs.
- Quality systems: change control; CAPA (deviations/OOSs); training; document control.
- GMPs, OSHA compliance, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing/plant equipment.
- Strong interpersonal, independent and team collaboration, communication, and organization.
Working Environment / Physical Environment
- On-site; exposure to in-lab environment; use required PPE.
- Lift/carry: frequently up to 35 lbs; occasionally up to 50 lbs.
Compensation/Benefits (as stated)
- Discretionary bonus and equity award.
- Base pay range: $88,200–$98,000 annually.
- Eligible benefits include medical/dental/vision; wellness programs; EAP; life/AD&D and disability; FSA; 401(k) match; 529; PTO (11 holidays) and other PTO details.
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).