Validation Engineer III

Validation Engineer IIIImmunityBio, Inc. 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. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. 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. The goal: to reprogram the patient's immune system and treat the host rather than just the disease.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 FunctionsLead interaction and collaboration with cross-functional departments in order to meet company expectationsLead and perform validation activities for equipment, utility systems, facilities, processes, and automation systems in compliance with approved SOPs, cGMPs, and applicable regulatory requirementsGenerate 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 environmentAuthor and review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systemsGenerate and keep current inventory of GMP systems and requalification/revalidation schedulesPerform risk assessments for GMP systems as requiredPlan validation efforts according to riskCollaborate with clients, CMO's, and vendors to meet project and company objectivesOwn the communications process with vendorsTroubleshoot and resolve discrepancies reported during validation/qualificationTroubleshoot, coordinate, and resolve failure investigations for manufacturing and laboratory equipmentProvide technical input to assist in development of project planningProvide 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 applicableLead audits and regulatory agency inspections for ValidationServe as subject matter expert in areas of IQ/OQ/PQ at a minimumOversee contractors, projects and timelinesCoordinate multiple projects and shifting prioritiesTrain end users on validation policies and requirements to support GMP operationsProvide validation assistance to other departments and perform any additional responsibilities as requested or assignedPerform ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.Basic QualificationsBachelor'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 QualificationsExcellent technical document writing and reviewing with teamsExcellent knowledge of validation principles including commissioning, IQ/OQ/PQs related to equipment and facilitiesStrong knowledge of process validation principlesExperience with project management conceptsExperience 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 systemsWorking knowledge of GMPs, OSHA compliance, 21 CFR Part 11 and cleanrooms, automated biopharmaceutical processing and plant equipmentGood interpersonal skills and the ability to work well in a team environmentExcellent communication and organizational skillsWorking Environment / Physical EnvironmentThis position works on-site.Exposure to onsite in-lab environmentMust be able to don and wear Personal Protective Equipment (PPE) as requiredLifting, standing, climbing, bending, grasping, sitting, pulling, pushing, stooping, stretching, and carrying are generally required to perform the functions of this positionMust 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 poundsThis position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is $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. 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.