Bachelor's degree in science or related discipline is required.
3+ years of relevant validation or GMP‑regulated industry experience is required.
Experience with facility commissioning and validation of equipment and facilities is required.
Strong technical document writing and reviewing with teams
Strong understanding and application of validation principles, concepts, practices, and industry standards.
Working knowledge of validation principles including commissioning, IQ/OQ/PQs related to equipment and facilities
Working knowledge of related quality systems such as change control; CAPA (including deviations/OOSs); training and document control is required.
Working knowledge of GMPs, OSHA compliance, 21 CFR Part 11 and cleanrooms, automated biopharmaceutical processing and plant equipment
Strong interpersonal skills and the ability to work well independently and in a team environment
Strong 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.
$103,500 (entry-level qualifications) to $115,000 (highly experienced) annually
Company Overview
ImmunityBio, Inc. (NASDAQ: 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. 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.
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 II is responsible for generating and executing protocols, creating summary reports and executing validation activities in FDA regulated biopharmaceutical environments. Coordinates all validation activities by constant communication with affected departments and personnel. Will report to a manager or head of the department. The Validation Engineer II works on many phases/sub-tasks of projects of moderate complexity and working under general supervision or mostly independently with minimal supervision.
Essential Functions
Collaborate with cross-functional departments to meet company expectations,
Perform validation activities for equipment, utility systems, facilities, processes, and automation systems in compliance with approved SOPs, cGMPs, and applicable regulatory requirements.
Generate, support 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/periodic review schedules,
Perform and lead risk assessments for GMP systems as required,
Plan validation efforts according to risk,
Collaborate with clients, CMOs, and vendors to meet project and company objectives,
Assist with vendor communications,
Troubleshoots and resolve discrepancy reported during validation/qualification.
Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.
Nant · El Segundo CA Duley