Validation Engineer III

Company Overview ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.


Why ImmunityBio?

• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.

• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.

• Work with a collaborative team with the ability to work across different areas of the company.

• Ability to join a growing company with professional development opportunities.

POSITION SUMMARY

The Validation Engineer III is responsible for coordinating all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Prepares all protocols, executing of protocols and reports for validation work in a FDA regulated biopharmaceutical environments. The Validation Engineer III reports to a manager or head of a unit/department. The Validation Engineer III contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. This includes oversight of contractors as we supplement validation staff during expansion activities.

ESSENTIAL FUNCTIONS

• Lead interaction and collaboration with cross-functional departments in order to meet company expectations
• Lead and perform validation activities for equipment, utility systems, facilities, processes, and automation systems in compliance with approved SOPs, cGMPs, and applicable regulatory requirements,
• Generate and execute validation protocols (IQ/OQ/PQ/CV/PV) of all site equipment including laboratory equipment, production equipment, utilities (as applicable) and other related systems in an FDA regulated environment,
• Author and review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems,
• Generate and keep current inventory of GMP systems and requalification/revalidation schedules,
• Perform risk assessments for GMP systems as required,
• Plan validation efforts according to risk,
• Collaborate with clients, CMO's, and vendors to meet project and company objectives,
• Own the communications process with vendors
• Troubleshoot and resolve discrepancies reported during validation/qualification
• Troubleshoot, coordinate, and resolve failure investigations for manufacturing and laboratory equipment,
• Provide technical input to assist in development of project planning,
• Provide technical project management deliverables for certain phases of a project including but not limited to scheduling, design, estimates, engineering specifications, drawings, materials procurement, construction contracts, cost tracking and project cost projections.
• Partner with engineering studies and investigation studies as applicable
• Lead audits and regulatory agency inspections for Validation,
• Serve as subject matter expert in areas of IQ/OQ/PQ at a minimum,
• Oversee contractors, projects and timelines,
• Coordinate multiple projects and shifting priorities,
• Train end users on validation policies and requirements to support GMP operations,
• Provide validation assistance to other departments and perform any additional responsibilities as requested or assigned,
• Perform ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

BASIC QUALIFICATIONS

• Bachelor's degree in science or related discipline is required.
• 5+ years of relevant validation or GMP-regulated industry experience is required.
• Experience with facility commissioning and validation of equipment and facilities is required.

PREFERRED QUALIFICATIONS

• Excellent technical document writing and reviewing with teams
• Excellent knowledge of validation principles including commissioning, IQ/OQ/PQs related to equipment and facilities
• Strong knowledge of process validation principles
• Experience with project management concepts
• Experience with and knowledge of related quality systems such as change control; CAPA (including deviations/OOSs); training and document control is required.
• Experience with ELLAB data loggers and systems
• Working knowledge of GMPs, OSHA compliance, 21 CFR Part 11 and cleanrooms, automated biopharmaceutical processing and plant equipment
• Good interpersonal skills and the ability to work well in a team environment
• Excellent communication and organizational skills

Working Environment / Physical Environment

• This position works on-site.
• Exposure to onsite in-lab environment
• Must be able to don and wear Personal Protective Equipment (PPE) as required
• Lifting, standing, climbing, bending, grasping, sitting, pulling, pushing, stooping, stretching, and carrying are generally required to perform the functions of this position
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Must be able to lift frequently lift up to 35 pounds and occasionally lift/move 50 pounds

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.

$115,500 (entry-level qualifications) to $128,000 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.

Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.

We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: 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) includes: 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 • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.


At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.