Validation Engineer II
ImmunityBio, Inc.
August 29, 2026
On-site
El Segundo, CA
Operations
Position Summary:
The Validation Engineer II generates and executes validation protocols and activities in FDA-regulated biopharmaceutical environments. Coordinates validation activities through constant communication with affected departments. 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 in compliance with approved SOPs, cGMPs, and applicable regulatory requirements.
- Generate, support, and execute validation protocols (IQ/OQ/PQ/CV/PV) for site equipment, laboratory/production equipment, utilities (as applicable), and related systems.
- 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 as required; plan validation efforts according to risk.
- Collaborate with clients, CMOs, and vendors; assist with vendor communications.
- Troubleshoot and resolve discrepancies during validation/qualification.
- Perform ad-hoc/cross-functional duties and/or projects to support business needs.
Basic Qualifications:
- Bachelor’s degree in science or related discipline (required).
- 3+ years validation or GMP-regulated industry experience (required).
- Facility commissioning and validation of equipment/facilities (required).
Preferred Qualifications:
- Strong technical document writing/reviewing.
- Validation principles/industry standards knowledge; commissioning and IQ/OQ/PQ for equipment/facilities.
- Quality system knowledge: change control; CAPA (deviations/OOSs); training and 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; wellness programs; EAP; life/AD&D; short/long-term disability.
- Flexible spending accounts; 401(k) with company match; 529 education savings.
- Paid time off (11 holidays) plus unlimited PTO for exempt or vacation/health/personal/cultural days for non-exempt.
- Employer-paid tools/resources for health and wellness.
Application Instructions:
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).
The Validation Engineer II generates and executes validation protocols and activities in FDA-regulated biopharmaceutical environments. Coordinates validation activities through constant communication with affected departments. 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 in compliance with approved SOPs, cGMPs, and applicable regulatory requirements.
- Generate, support, and execute validation protocols (IQ/OQ/PQ/CV/PV) for site equipment, laboratory/production equipment, utilities (as applicable), and related systems.
- 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 as required; plan validation efforts according to risk.
- Collaborate with clients, CMOs, and vendors; assist with vendor communications.
- Troubleshoot and resolve discrepancies during validation/qualification.
- Perform ad-hoc/cross-functional duties and/or projects to support business needs.
Basic Qualifications:
- Bachelor’s degree in science or related discipline (required).
- 3+ years validation or GMP-regulated industry experience (required).
- Facility commissioning and validation of equipment/facilities (required).
Preferred Qualifications:
- Strong technical document writing/reviewing.
- Validation principles/industry standards knowledge; commissioning and IQ/OQ/PQ for equipment/facilities.
- Quality system knowledge: change control; CAPA (deviations/OOSs); training and 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; wellness programs; EAP; life/AD&D; short/long-term disability.
- Flexible spending accounts; 401(k) with company match; 529 education savings.
- Paid time off (11 holidays) plus unlimited PTO for exempt or vacation/health/personal/cultural days for non-exempt.
- Employer-paid tools/resources for health and wellness.
Application Instructions:
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).