Validation Engineer III

ImmunityBio, Inc. • Dunkirk, NY

4d • $115,500 - $128,000 • Onsite

About The Position

ImmunityBio, Inc. is a commercial-stage biotechnology company focused on developing cell and immunotherapy products designed to enhance the patient's natural immune system to combat diseases like cancer and infectious diseases. The company aims to transform patient lives by developing next-generation therapies and vaccines that harness and amplify the immune system. This role is with a publicly traded biopharmaceutical company headquartered in Southern California, offering opportunities to work with a collaborative team and grow professionally.

Requirements

• 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.

Nice To Haves

• 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

Responsibilities

• Coordinating all validation activities through constant communication with affected departments and personnel.
• Overseeing and reviewing validation area processes and procedures.
• Preparing all protocols, executing protocols, and writing reports for validation work in FDA-regulated biopharmaceutical environments.
• Leading interaction and collaboration with cross-functional departments to meet company expectations.
• Leading and performing validation activities for equipment, utility systems, facilities, processes, and automation systems in compliance with approved SOPs, cGMPs, and applicable regulatory requirements.
• Generating and executing validation protocols (IQ/OQ/PQ/CV/PV) for all site equipment, including laboratory equipment, production equipment, utilities, and other related systems in an FDA-regulated environment.
• Authoring and reviewing SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems.
• Generating and maintaining an inventory of GMP systems and requalification/revalidation schedules.
• Performing risk assessments for GMP systems as required.
• Planning validation efforts according to risk.
• Collaborating with clients, CMOs, and vendors to meet project and company objectives.
• Owning the communications process with vendors.
• Troubleshooting and resolving discrepancies reported during validation/qualification.
• Troubleshooting, coordinating, and resolving failure investigations for manufacturing and laboratory equipment.
• Providing technical input to assist in the development of project planning.
• Providing technical project management deliverables for certain phases of a project, including scheduling, design, estimates, engineering specifications, drawings, materials procurement, construction contracts, cost tracking, and project cost projections.
• Partnering with engineering studies and investigation studies as applicable.
• Leading audits and regulatory agency inspections for Validation.
• Serving as a subject matter expert in areas of IQ/OQ/PQ at a minimum.
• Overseeing contractors, projects, and timelines.
• Coordinating multiple projects and shifting priorities.
• Training end-users on validation policies and requirements to support GMP operations.
• Providing validation assistance to other departments and performing any additional responsibilities as requested or assigned.
• Performing ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Benefits

• Discretionary bonus
• Equity award
• 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
• Unlimited PTO (for Exempt Employees)
• 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day (for Non-Exempt Employees)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level