Validation Engineer II
ImmunityBio, Inc.
June 30, 2026
On-site
El Segundo, CA
Operations
Position Summary
The Validation Engineer II generates and executes protocols, summary reports, and validation activities in FDA-regulated biopharmaceutical environments. Coordinates validation activities with affected departments and personnel. Works under general supervision or mostly independently.
Essential Functions
- Collaborate cross-functionally.
- Perform validation of equipment, utility systems, facilities, processes, and automation systems in compliance with SOPs, cGMPs, and regulatory requirements.
- Generate/support/execute IQ/OQ/PQ/CV/PV for site equipment (lab, production, utilities as applicable) in an FDA-regulated environment.
- Author/review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems.
- Maintain GMP system inventory and requalification/periodic review schedules.
- Perform/lead GMP risk assessments; plan validation efforts based on risk.
- Coordinate with clients, CMOs, and vendors; assist with vendor communications.
- Troubleshoot and resolve discrepancies during validation/qualification.
- Perform ad-hoc/cross-functional duties supporting business needs.
Basic Qualifications
- Bachelor’s degree in science or related discipline.
- 3+ years validation or GMP-regulated industry experience.
- Experience with facility commissioning and validation of equipment/facilities.
Preferred Qualifications
- Technical document writing/reviewing.
- Validation principles and commissioning; IQ/OQ/PQs.
- 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, communication, and organizational skills.
Working Environment / Physical Environment
- On-site; in-lab exposure; PPE required.
- Able to lift frequently up to 35 lbs; occasionally move 50 lbs.
Benefits (eligible)
- Medical, dental, and vision plan options; wellness programs; EAP; life/AD&D and disability; FSAs; 401(k) match; 529; PTO (11 holidays for exempt/unlimited for exempt employees; specified vacation/personal days for non-exempt).
Application Instructions
- Application window expected to close 60 days from posting (or sooner if filled/closed).
The Validation Engineer II generates and executes protocols, summary reports, and validation activities in FDA-regulated biopharmaceutical environments. Coordinates validation activities with affected departments and personnel. Works under general supervision or mostly independently.
Essential Functions
- Collaborate cross-functionally.
- Perform validation of equipment, utility systems, facilities, processes, and automation systems in compliance with SOPs, cGMPs, and regulatory requirements.
- Generate/support/execute IQ/OQ/PQ/CV/PV for site equipment (lab, production, utilities as applicable) in an FDA-regulated environment.
- Author/review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems.
- Maintain GMP system inventory and requalification/periodic review schedules.
- Perform/lead GMP risk assessments; plan validation efforts based on risk.
- Coordinate with clients, CMOs, and vendors; assist with vendor communications.
- Troubleshoot and resolve discrepancies during validation/qualification.
- Perform ad-hoc/cross-functional duties supporting business needs.
Basic Qualifications
- Bachelor’s degree in science or related discipline.
- 3+ years validation or GMP-regulated industry experience.
- Experience with facility commissioning and validation of equipment/facilities.
Preferred Qualifications
- Technical document writing/reviewing.
- Validation principles and commissioning; IQ/OQ/PQs.
- 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, communication, and organizational skills.
Working Environment / Physical Environment
- On-site; in-lab exposure; PPE required.
- Able to lift frequently up to 35 lbs; occasionally move 50 lbs.
Benefits (eligible)
- Medical, dental, and vision plan options; wellness programs; EAP; life/AD&D and disability; FSAs; 401(k) match; 529; PTO (11 holidays for exempt/unlimited for exempt employees; specified vacation/personal days for non-exempt).
Application Instructions
- Application window expected to close 60 days from posting (or sooner if filled/closed).