Principal Validation Engineer
ImmunityBio, Inc.
August 22, 2026
On-site
El Segundo, CA
Operations
Principal Validation Engineer
Essential Functions/Responsibilities:
- Coordinate all validation activities; communicate with affected departments and oversee validation processes/procedures.
- Engage cross-functionally to define validation requirements, plans, strategies; design, verification and validation.
- Generate and execute IQ/OQ/PQ protocols for site equipment and related systems in an FDA-regulated biopharmaceutical environment.
- Provide technical project management (scheduling, specifications, drawings, materials procurement).
- Author/review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems.
- Perform risk assessments and plan validation based on risk.
- Support process improvements using Lean Six Sigma or Quality by Design.
- Manage contractors, projects, and timelines; mentor junior Validation Engineers; train end users.
- Collaborate with clients/CMOs/vendors; participate in validation audits/regulatory inspections.
- Serve as subject matter expert for qualification/validation; troubleshoot and coordinate failure investigations.
- Resolve deviations/non-conformances; maintain GMP system inventory and requalification/revalidation schedules; support vendor maintenance/repair.
Qualifications:
- Bachelor’s degree in science (or related) required.
- 10+ years validation or GMP-regulated industry experience required.
- Experience with facility/equipment commissioning, qualification and validation required.
Skills/Knowledge (required/preferred):
- Strong technical document writing/review; validation principles (IQ/OQ/PQ).
- Quality systems: change control, CAPA, risk assessment (FMEA), training/document control.
- Working knowledge of GMPs, OSHA, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing.
- Lean Six Sigma and/or Quality by Design.
- Preferred: experience with ELLAB data loggers/systems.
Benefits/Compensation (explicitly stated):
- Eligible for discretionary bonus and equity award.
Application instruction (explicitly stated):
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).
Essential Functions/Responsibilities:
- Coordinate all validation activities; communicate with affected departments and oversee validation processes/procedures.
- Engage cross-functionally to define validation requirements, plans, strategies; design, verification and validation.
- Generate and execute IQ/OQ/PQ protocols for site equipment and related systems in an FDA-regulated biopharmaceutical environment.
- Provide technical project management (scheduling, specifications, drawings, materials procurement).
- Author/review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems.
- Perform risk assessments and plan validation based on risk.
- Support process improvements using Lean Six Sigma or Quality by Design.
- Manage contractors, projects, and timelines; mentor junior Validation Engineers; train end users.
- Collaborate with clients/CMOs/vendors; participate in validation audits/regulatory inspections.
- Serve as subject matter expert for qualification/validation; troubleshoot and coordinate failure investigations.
- Resolve deviations/non-conformances; maintain GMP system inventory and requalification/revalidation schedules; support vendor maintenance/repair.
Qualifications:
- Bachelor’s degree in science (or related) required.
- 10+ years validation or GMP-regulated industry experience required.
- Experience with facility/equipment commissioning, qualification and validation required.
Skills/Knowledge (required/preferred):
- Strong technical document writing/review; validation principles (IQ/OQ/PQ).
- Quality systems: change control, CAPA, risk assessment (FMEA), training/document control.
- Working knowledge of GMPs, OSHA, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing.
- Lean Six Sigma and/or Quality by Design.
- Preferred: experience with ELLAB data loggers/systems.
Benefits/Compensation (explicitly stated):
- Eligible for discretionary bonus and equity award.
Application instruction (explicitly stated):
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).