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Facilities Process Engineer II
4 months ago
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
As part of the Engineering Team, the Facilities Process Engineer ll is responsible for maintaining, troubleshooting, and improving existing process equipment, oversight of the selection/procurement/installation of new equipment, and assisting with projects to expand facilities in FDA regulated biopharmaceutical environments. The role requires close collaboration with facilities maintenance, GMP manufacturing, quality operations, leadership, and other functions to ensure successful ongoing manufacturing operations, while also expanding those operations.
Essential Functions
- Effectively interact and collaborate with cross-functional departments in order to meet company expectations
- Serve as subject matter expert for assigned processes, equipment, and utilities
- Manage small projects that require internal function oversight, develop project scope and timelines
- Assist with multiple larger projects by representing engineering in a dynamic and changing environment
- Identify appropriate vendors/contractors, develop requests for proposal, manage the onboarding of new vendors/contractors
- Troubleshoot and coordinate investigations of manufacturing and laboratory processes
- Assist with vendor communications and maintenance/repair scheduling by placing work orders
- Lead teams to address deviations and non-conformances by performing root cause analysis
- Develop and implement preventive actions and corrective actions
- Author and review SOPs, protocols, change controls
- Mentor, coach, train junior engineers or technicians on engineering policies and requirements to support GMPs
- Lead engineering design reviews as needed
- Collaborate with clients, contract manufacturers, and vendors to meet project and company objectives
- Participate in audits and regulatory agency inspections, as needed
- Perform all other duties as assigned
Education & Experience
- Bachelor's degree in Engineering or other technical discipline with 2-5 years of relevant work experience
- Pharma/Biotech industry experience preferred
- Good Manufacturing Practices (GMP) experience is required
- Operations support in a GMP manufacturing environment
- Experience with equipment/process troubleshooting and repair
- Experience with facility and equipment commissioning and validation is preferred
- Experienced in developing project scope, project budget, and ability to lead small projects is beneficial
Knowledge, Skills, & Abilities
- Good interpersonal skills and the ability to work well in a team environment
- Good technical writing, communication, and organizational skills
- Knowledge of engineering principles required to support GMP facilities and equipment
- Experience with commissioning, IQ/OQ/PQs for GMP equipment and facilities
- Experience with and knowledge of related quality systems such as change control; CAPA (including deviations/OOSs); training and document control.
- Working knowledge of GMP, OSHA compliance, 21 CFR Part 11 and cleanrooms, automated biopharmaceutical processing, and plant equipment
Working Environment / Physical Environment
- Exposure to onsite in-lab environment
- Ability to work in a standing position for long periods of time on a day-to-day basis (up to 8 hours).
- Ability to reach, bend, stoop, push and/or pull, and 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.
$100,000 (entry-level qualifications) to $125,000 (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.
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.