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 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.