Position SummaryThe 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.
Essential Functions- 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.
Basic Qualifications- 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.
Preferred Qualifications- 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
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.
$88,200 (entry-level qualifications) to $98,000 (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.
