Validation Engineer III
ImmunityBio, Inc.
June 30, 2026
On-site
Dunkirk, NY
Operations
Position Summary
The Validation Engineer III coordinates validation activities across departments and oversees/reviews validation processes and procedures in FDA-regulated biopharmaceutical environments. Prepares protocols, executes protocols, and reports validation work.
Essential Functions / Responsibilities
- Lead cross-functional collaboration to meet company expectations.
- Perform validation of equipment, utilities, facilities, processes, and automation systems per SOPs, cGMPs, and regulatory requirements.
- Generate/execute IQ/OQ/PQ/CV/PV protocols for site systems (laboratory, production, utilities as applicable).
- Author/review SOPs, protocols, reports, and validation master plans for GMP equipment/instruments/computerized systems.
- Maintain GMP system inventory and requalification/revalidation schedules; perform risk assessments; plan validation by risk.
- Coordinate with clients, CMOs, and vendors; own vendor communications.
- Troubleshoot discrepancies and resolve failure investigations for manufacturing/lab equipment.
- Provide technical input and technical project management deliverables (e.g., scheduling, estimates, specifications/drawings, procurement, contracts, cost tracking).
- Partner with engineering/investigation studies; lead validation audits and regulatory inspections.
- Serve as SME for IQ/OQ/PQ; oversee contractors; coordinate multiple projects/priorities.
- Train end users on validation policies/requirements.
Basic Qualifications
- Bachelor’s degree in science or related discipline.
- 5+ years validation or GMP-regulated industry experience.
- Experience with facility commissioning and validation of equipment/facilities.
Preferred Qualifications
- Strong technical document writing/review; validation principles (commissioning, IQ/OQ/PQ); process validation.
- Project management experience.
- Quality systems knowledge (change control; CAPA/deviations/OOS; training; document control).
- ELLAB data loggers/systems; GMPs/OSHA/21 CFR Part 11/cleanrooms; automated biopharmaceutical processing; plant equipment.
- Interpersonal, communication, and organizational skills.
Benefits (explicitly stated)
- Medical, dental, vision; wellness programs; EAP; life/AD&D and short/long-term disability; FSA; 401(k) match; 529; PTO (11 holidays; exempt: unlimited; non-exempt: vacation/health pay/personal/cultural days).
Application Instruction
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).
The Validation Engineer III coordinates validation activities across departments and oversees/reviews validation processes and procedures in FDA-regulated biopharmaceutical environments. Prepares protocols, executes protocols, and reports validation work.
Essential Functions / Responsibilities
- Lead cross-functional collaboration to meet company expectations.
- Perform validation of equipment, utilities, facilities, processes, and automation systems per SOPs, cGMPs, and regulatory requirements.
- Generate/execute IQ/OQ/PQ/CV/PV protocols for site systems (laboratory, production, utilities as applicable).
- Author/review SOPs, protocols, reports, and validation master plans for GMP equipment/instruments/computerized systems.
- Maintain GMP system inventory and requalification/revalidation schedules; perform risk assessments; plan validation by risk.
- Coordinate with clients, CMOs, and vendors; own vendor communications.
- Troubleshoot discrepancies and resolve failure investigations for manufacturing/lab equipment.
- Provide technical input and technical project management deliverables (e.g., scheduling, estimates, specifications/drawings, procurement, contracts, cost tracking).
- Partner with engineering/investigation studies; lead validation audits and regulatory inspections.
- Serve as SME for IQ/OQ/PQ; oversee contractors; coordinate multiple projects/priorities.
- Train end users on validation policies/requirements.
Basic Qualifications
- Bachelor’s degree in science or related discipline.
- 5+ years validation or GMP-regulated industry experience.
- Experience with facility commissioning and validation of equipment/facilities.
Preferred Qualifications
- Strong technical document writing/review; validation principles (commissioning, IQ/OQ/PQ); process validation.
- Project management experience.
- Quality systems knowledge (change control; CAPA/deviations/OOS; training; document control).
- ELLAB data loggers/systems; GMPs/OSHA/21 CFR Part 11/cleanrooms; automated biopharmaceutical processing; plant equipment.
- Interpersonal, communication, and organizational skills.
Benefits (explicitly stated)
- Medical, dental, vision; wellness programs; EAP; life/AD&D and short/long-term disability; FSA; 401(k) match; 529; PTO (11 holidays; exempt: unlimited; non-exempt: vacation/health pay/personal/cultural days).
Application Instruction
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).