Validation Engineering Tech

IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. 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.
• Ability to join a growing company with professional development opportunities.

The Validation Engineer III is responsible for coordinating all validation activities by constant communication with affected departments and personnel; 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. This includes oversight of contractors as we supplement validation staff during expansion activities.
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,
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,
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.
Bachelor's degree in science or related discipline is required.
~Experience with facility commissioning and validation of equipment and facilities is required.

Excellent technical document writing and reviewing with teams
Excellent knowledge of validation principles including commissioning, IQ/OQ/PQs related to equipment and facilities
Experience with project management concepts
Experience with and knowledge of related quality systems such as change control; 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
This position works on-site.
Must be able to don and wear Personal Protective Equipment (PPE) as required
Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
This position is eligible for a discretionary bonus and equity award. 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 employees are as valuable as the people we serve. 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.