Manager, Validation
ImmunityBio, Inc.
4 days ago
On-site
Dunkirk, NY
Operations
Position Summary
The Manager, Validation is a hands-on leader responsible for leading validation staff in qualification activities to meet company objectives in FDA-regulated biopharmaceutical environments.
Responsibilities
- Provide leadership and technical support for validation; justify validation budgets, capacity, personnel, and equipment needs.
- Plan, coordinate, and track validation project progress.
- Interface with Engineering, Manufacturing, Regulatory Affairs, and other teams.
- Oversee commissioning, cleaning validation, process validation, and equipment qualifications for equipment, utilities, and facilities.
- Develop and execute validation protocols (IQ/OQ/PQ/PV/CV); review/approve SOPs, protocols, reports, and validation master plans.
- Lead validation scope planning; maintain requalification/revalidation schedules.
- Oversee/manage staff and contractors; train end-users on validation policies.
- Conduct QRM risk assessments; manage deviations, change controls, and CAPAs.
- Report validation metrics; apply Six Sigma Lean approaches.
- Mentor/coach validation staff; collaborate with Talent Acquisition, clients/CMOs/vendors.
- Participate in audits/inspections; serve as Validation subject matter expert.
- Lead investigations for validation discrepancies and ensure documentation/closure.
- Create work orders for calibration/maintenance/repairs; collaborate with CSV to validate computer systems.
- Support domestic site validation activities; implement qualification practices for process improvement.
- Perform ad-hoc/cross-functional projects.
Qualifications
- Bachelor’s degree in science or related discipline (required).
- 10+ years validation or GMP-regulated industry experience (required).
- Experience with facility commissioning and validation of equipment/facilities (required).
- 5+ years management experience (preferred).
Required/Preferred Skills
- Strong knowledge of commissioning, qualification, validation; process validation principles; project management.
- GMP, OSHA compliance, 21 CFR Part 11, cleanrooms; automated biopharmaceutical processing/plant equipment.
- Experience with quality systems (change control, work order and document control).
- Critical thinking, root-cause investigation, and technical documentation skills.
- Experience with ELLAB data loggers/systems.
Benefits
- Eligible for discretionary bonus and equity award.
Application
- Application window anticipated to close 60 days from posting or sooner if filled/closed.
The Manager, Validation is a hands-on leader responsible for leading validation staff in qualification activities to meet company objectives in FDA-regulated biopharmaceutical environments.
Responsibilities
- Provide leadership and technical support for validation; justify validation budgets, capacity, personnel, and equipment needs.
- Plan, coordinate, and track validation project progress.
- Interface with Engineering, Manufacturing, Regulatory Affairs, and other teams.
- Oversee commissioning, cleaning validation, process validation, and equipment qualifications for equipment, utilities, and facilities.
- Develop and execute validation protocols (IQ/OQ/PQ/PV/CV); review/approve SOPs, protocols, reports, and validation master plans.
- Lead validation scope planning; maintain requalification/revalidation schedules.
- Oversee/manage staff and contractors; train end-users on validation policies.
- Conduct QRM risk assessments; manage deviations, change controls, and CAPAs.
- Report validation metrics; apply Six Sigma Lean approaches.
- Mentor/coach validation staff; collaborate with Talent Acquisition, clients/CMOs/vendors.
- Participate in audits/inspections; serve as Validation subject matter expert.
- Lead investigations for validation discrepancies and ensure documentation/closure.
- Create work orders for calibration/maintenance/repairs; collaborate with CSV to validate computer systems.
- Support domestic site validation activities; implement qualification practices for process improvement.
- Perform ad-hoc/cross-functional projects.
Qualifications
- Bachelor’s degree in science or related discipline (required).
- 10+ years validation or GMP-regulated industry experience (required).
- Experience with facility commissioning and validation of equipment/facilities (required).
- 5+ years management experience (preferred).
Required/Preferred Skills
- Strong knowledge of commissioning, qualification, validation; process validation principles; project management.
- GMP, OSHA compliance, 21 CFR Part 11, cleanrooms; automated biopharmaceutical processing/plant equipment.
- Experience with quality systems (change control, work order and document control).
- Critical thinking, root-cause investigation, and technical documentation skills.
- Experience with ELLAB data loggers/systems.
Benefits
- Eligible for discretionary bonus and equity award.
Application
- Application window anticipated to close 60 days from posting or sooner if filled/closed.