Validation Engineer II
ImmunityBio, Inc.
August 17, 2026
On-site
El Segundo, CA
Operations
Position Summary:
The Validation Engineer II generates and executes protocols, creates summary reports, and performs validation activities in FDA regulated biopharmaceutical environments. Coordinates validation activities with affected departments and personnel. Works on multiple phases/sub-tasks of moderate complexity under general supervision or mostly independently.
Essential Functions:
- Collaborate with cross-functional departments to meet company expectations.
- Perform validation activities for equipment, utility systems, facilities, processes, and automation systems per approved SOPs, cGMPs, and regulatory requirements.
- Generate, support, and execute validation protocols (IQ/OQ/PQ/CV/PV).
- Author and review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems.
- Maintain inventory of GMP systems and requalification/periodic review schedules.
- Perform and lead risk assessments for GMP systems.
- Plan validation efforts based on risk.
- Collaborate with clients, CMOs, and vendors; assist with vendor communications.
- Troubleshoot and resolve discrepancies during validation/qualification.
- Perform ad-hoc/cross-functional duties/projects to support business needs.
Basic Qualifications:
- Bachelor’s degree in science or related discipline.
- 3+ years of validation or GMP-regulated industry experience.
- Experience with facility commissioning and validation of equipment and facilities.
Preferred Qualifications:
- Strong technical document writing/reviewing.
- Validation principles and standards knowledge.
- Working knowledge of commissioning and IQ/OQ/PQ for equipment and facilities.
- Quality systems knowledge: change control; CAPA; training; document control.
- GMPs, OSHA compliance, 21 CFR Part 11, cleanrooms; automated biopharmaceutical processing and plant equipment.
- Strong interpersonal, communication, and organizational skills.
Benefits:
- Discretionary bonus and equity award.
- Medical, Dental, and Vision Plan options; Health and Financial Wellness Programs; EAP; Life/AD&D; Short/Long-Term Disability; Flexible Spending Accounts; 401(k) match; 529; PTO (includes 11 holidays; Unlimited for Exempt or specified vacation/personal days for Non-Exempt).
Application Instructions:
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).
The Validation Engineer II generates and executes protocols, creates summary reports, and performs validation activities in FDA regulated biopharmaceutical environments. Coordinates validation activities with affected departments and personnel. Works on multiple phases/sub-tasks of moderate complexity under general supervision or mostly independently.
Essential Functions:
- Collaborate with cross-functional departments to meet company expectations.
- Perform validation activities for equipment, utility systems, facilities, processes, and automation systems per approved SOPs, cGMPs, and regulatory requirements.
- Generate, support, and execute validation protocols (IQ/OQ/PQ/CV/PV).
- Author and review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems.
- Maintain inventory of GMP systems and requalification/periodic review schedules.
- Perform and lead risk assessments for GMP systems.
- Plan validation efforts based on risk.
- Collaborate with clients, CMOs, and vendors; assist with vendor communications.
- Troubleshoot and resolve discrepancies during validation/qualification.
- Perform ad-hoc/cross-functional duties/projects to support business needs.
Basic Qualifications:
- Bachelor’s degree in science or related discipline.
- 3+ years of validation or GMP-regulated industry experience.
- Experience with facility commissioning and validation of equipment and facilities.
Preferred Qualifications:
- Strong technical document writing/reviewing.
- Validation principles and standards knowledge.
- Working knowledge of commissioning and IQ/OQ/PQ for equipment and facilities.
- Quality systems knowledge: change control; CAPA; training; document control.
- GMPs, OSHA compliance, 21 CFR Part 11, cleanrooms; automated biopharmaceutical processing and plant equipment.
- Strong interpersonal, communication, and organizational skills.
Benefits:
- Discretionary bonus and equity award.
- Medical, Dental, and Vision Plan options; Health and Financial Wellness Programs; EAP; Life/AD&D; Short/Long-Term Disability; Flexible Spending Accounts; 401(k) match; 529; PTO (includes 11 holidays; Unlimited for Exempt or specified vacation/personal days for Non-Exempt).
Application Instructions:
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).