Manager, Validation
ImmunityBio, Inc.
June 25, 2026
On-site
Dunkirk, NY
Operations
Position Summary
The Manager, Validation is responsible for being a hands-on leader to the validation staff as they perform qualification activities needed to meet company objectives in an FDA regulated biopharmaceutical environment. Responsibilities
- Provide leadership and technical support for validation; define, recommend, and justify validation budgets, capacity, personnel, and equipment needs.
- Plan, coordinate, and track validation projects; interface with Engineering, Manufacturing, Regulatory Affairs, etc.
- Oversee and support commissioning, cleaning validation, process validation, and equipment qualifications for equipment, utilities, and facilities.
- Collaborate cross-functionally to define qualification requirements; establish timelines and ensure compliance.
- Generate/execute validation protocols (IQ/OQ/PQ/PV/CV); review/approve SOPs, protocols, reports, and validation master plans.
- Lead validation scope planning meetings; maintain schedules for GMP requalification/revalidation.
- Oversee/manage team and contractors; train end-users; perform risk assessments (QRM).
- Manage deviations, change controls, and CAPAs (QMS); report validation metrics.
- Apply Six Sigma Lean; mentor/coach validation staff.
- Coordinate with CSV team for computer system validation; support domestic site validation activities.
- Serve as subject matter expert; lead validation discrepancy investigations.
- Create work orders for calibrations/maintenance/repairs; manage performance reviews; support audits/inspections.
- Implement streamlined qualification practices and perform ad-hoc cross-functional duties.
Education/Experience
- Bachelor’s degree in science or related discipline (required).
- 10+ years validation or GMP-regulated industry experience (required).
- Facility commissioning and validation of equipment/facilities (required).
- 5+ years management experience (preferred).
Skills/Abilities
- Strong project management and planning; excellent communication and technical documentation.
- Deep knowledge of commissioning/qualification/validation and process validation principles.
- Knowledge of TQM, QRM, change control/work orders/document control.
- Working knowledge of GMPs, OSHA compliance, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing.
- Experience with ELLAB data loggers/systems.
Benefits
- Discretionary bonus and equity award.
- Base pay range: $144,000 to $160,000 annually.
- Eligible benefits include Medical/Dental/Vision, wellness programs, EAP, life/AD&D, STD/LTD, healthcare/dependent care FSA, 401(k) match, 529 plan, PTO (11 holidays; unlimited for exempt; vacation/health/personal/cultural days for non-exempt).
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).
The Manager, Validation is responsible for being a hands-on leader to the validation staff as they perform qualification activities needed to meet company objectives in an FDA regulated biopharmaceutical environment. Responsibilities
- Provide leadership and technical support for validation; define, recommend, and justify validation budgets, capacity, personnel, and equipment needs.
- Plan, coordinate, and track validation projects; interface with Engineering, Manufacturing, Regulatory Affairs, etc.
- Oversee and support commissioning, cleaning validation, process validation, and equipment qualifications for equipment, utilities, and facilities.
- Collaborate cross-functionally to define qualification requirements; establish timelines and ensure compliance.
- Generate/execute validation protocols (IQ/OQ/PQ/PV/CV); review/approve SOPs, protocols, reports, and validation master plans.
- Lead validation scope planning meetings; maintain schedules for GMP requalification/revalidation.
- Oversee/manage team and contractors; train end-users; perform risk assessments (QRM).
- Manage deviations, change controls, and CAPAs (QMS); report validation metrics.
- Apply Six Sigma Lean; mentor/coach validation staff.
- Coordinate with CSV team for computer system validation; support domestic site validation activities.
- Serve as subject matter expert; lead validation discrepancy investigations.
- Create work orders for calibrations/maintenance/repairs; manage performance reviews; support audits/inspections.
- Implement streamlined qualification practices and perform ad-hoc cross-functional duties.
Education/Experience
- Bachelor’s degree in science or related discipline (required).
- 10+ years validation or GMP-regulated industry experience (required).
- Facility commissioning and validation of equipment/facilities (required).
- 5+ years management experience (preferred).
Skills/Abilities
- Strong project management and planning; excellent communication and technical documentation.
- Deep knowledge of commissioning/qualification/validation and process validation principles.
- Knowledge of TQM, QRM, change control/work orders/document control.
- Working knowledge of GMPs, OSHA compliance, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing.
- Experience with ELLAB data loggers/systems.
Benefits
- Discretionary bonus and equity award.
- Base pay range: $144,000 to $160,000 annually.
- Eligible benefits include Medical/Dental/Vision, wellness programs, EAP, life/AD&D, STD/LTD, healthcare/dependent care FSA, 401(k) match, 529 plan, PTO (11 holidays; unlimited for exempt; vacation/health/personal/cultural days for non-exempt).
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).