Principal Validation Engineer

ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products designed to strengthen each patient’s natural immune system, enabling it to outsmart disease and eliminate cancerous or infected cells. Our vision is to conquer cancer by reprogramming the immune system to treat the host rather than just the disease.

About the role

The Principal Validation Engineer coordinates all validation activities, oversees processes, and prepares protocols, executions, and reports for validation work in an FDA-regulated biopharmaceutical environment. This role includes managing contractors during expansion activities and serving as a subject matter expert in qualification and validation.

Responsibilities

• Provide validation-focused design and development by engaging with cross-functional teams to define requirements, design, verification, and validation plans.
• Generate and execute validation protocols (IQ/OQ/PQ) for site equipment, including laboratory equipment, production equipment, utilities, and related systems in an FDA-regulated environment.
• Provide technical project management for project phases, including scheduling, design, engineering specifications, drawings, and materials procurement.
• Author and review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems.
• Perform risk assessments for GMP systems and plan validation efforts according to risk.
• Evaluate systems for potential process improvements using Lean Six Sigma or Quality by Design approaches.
• Support managers in holding delivery teams accountable for assignments.
• Manage contractors, projects, and timelines, coordinating multiple projects and shifting priorities.
• Mentor and guide junior Validation Engineers across multiple teams and projects.
• Train end users on validation policies and requirements to support GMP operations.
• Collaborate with clients, CMOs, and vendors to meet project and company objectives.
• Participate in audits and regulatory agency inspections for Validation.
• Troubleshoot and coordinate failure investigations for manufacturing and laboratory equipment.
• Assist with vendor communications and maintenance/repair scheduling.
• Resolve deviations and non-conformances reported during validation/qualification.
• Assist with engineering studies and investigations in other departments.
• Generate and maintain an inventory of GMP systems and requalification/revalidation schedules.
• Create, edit, and adhere to Standard Operating Procedures (SOPs) and process improvements.
• Perform ad-hoc and cross-functional duties/projects to support business needs.

Requirements

• Bachelor’s degree in science or a related discipline.
• 10+ years of relevant validation or GMP-regulated industry experience.
• Experience with facility and equipment commissioning, qualification, and validation.

Skills

• Excellent technical document writing and reviewing with teams.
• Strong knowledge of validation principles, including commissioning, IQ/OQ/PQs for equipment and facilities.
• Experience with quality systems such as change control, CAPA (including deviations/OOSs), risk assessment (FMEA), training, and document control.
• Experience with ELLAB data loggers and systems (preferred).
• Working knowledge of GMPs, OSHA compliance, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing, and plant equipment.
• Working knowledge of Lean Six Sigma and/or Quality by Design approaches.
• Strong interpersonal skills and ability to work independently and collaboratively.
• Excellent communication and organizational skills.

Working Environment

• On-site position with exposure to an in-lab environment.
• Must be able to wear Personal Protective Equipment (PPE) as required.
• Requires lifting, standing, climbing, bending, grasping, sitting, pulling, pushing, stooping, stretching, and carrying (frequently up to 35 pounds, occasionally up to 50 pounds).
• Must possess mobility to work in a standard office setting and use standard office equipment, including a computer.

Pay

The annual base pay range for this position is $148,500 (entry-level qualifications) to $165,000 (highly experienced), depending on qualifications, prior experience, and geographic location.

Benefits

• Medical, Dental, and Vision Plan Options.
• Health and Financial Wellness Programs.
• Employer Assistance Program (EAP).
• Company-paid and voluntary Life/AD&D, Short-Term and Long-Term Disability.
• Healthcare and Dependent Care Flexible Spending Accounts.
• 401(k) Retirement Plan with Company Match.
• 529 Education Savings Program.
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance, and Employee Discounts, Rewards, and Perks.
• Paid Time Off (PTO) including 11 holidays.
• Exempt employees are eligible for unlimited PTO.
• Non-exempt employees are eligible for 10 vacation days, 56 hours of health pay, 2 personal days, and 1 cultural day.