Validation Engineer I

ImmunityBio, Inc.•El Segundo, CA

2d•$88,200 - $98,000•Onsite

About The Position

The Validation Engineer I is responsible for generating and executing protocols, creating summary reports and executing validation activities in FDA regulated biopharmaceutical environments. The role coordinates all validation activities by constant communication with affected departments and personnel. The Validation Engineer I works on projects and matters of minimal complexity in a support role and works closely with senior staff.

Requirements

Bachelor’s degree in a science or related discipline is required.
1+ 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

Good technical document writing and reviewing with teams
Good 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
Good interpersonal skills and the ability to work well independently and in a team environment
Good communication and organizational skills

Responsibilities

Support collaboration with cross-functional departments, clients, CMOs, and vendors to meet project and company expectations and objectives.
Assist in 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.
Generate and keep current inventory of GMP systems and requalification/periodic reviews schedules.
Perform risk assessments for GMP systems as required.
Plan validation efforts according to risk.
Troubleshoot discrepancies reported during validation/qualification and assist senior engineers with resolutions.
Support the Validation team purchasing acquisitions and oversee the supplies and equipment inventory as needed.
Adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
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