Validation Engineer II

ImmunityBio, Inc.•El Segundo, CA

1d•$103,500 - $115,000•Onsite

About The Position

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.

Requirements

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.
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

Nice To Haves

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
Strong interpersonal skills and the ability to work well independently and in a team environment
Strong communication and organizational skills

Responsibilities

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.

Benefits

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