Manager, Engineering - Capex Projects

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 Manager, Engineering- Capex Projects is responsible for providing leadership for overseeing the planning, execution, and delivery of capital construction projects within Good Manufacturing Practice (GMP) regulated environments. This individual serves as the primary technical authority and project owner for commercial construction initiatives, ensuring all projects meet regulatory compliance, engineering standards, cost targets, and schedule milestones. The role requires close collaboration with facilities maintenance, project management, manufacturing operations, quality operations, site leadership, contractors and other functions to ensure successful ongoing manufacturing operations, while also expanding those operations.

Essential Functions

• Lead Major Capex projects from concept design, RFP, buildout, commissioning, and handover to users. Includes project plans, budgets, schedule, and vendor management
• Manage Contractors and Engineers to ensure designs/equipment are installed to ImmunityBio standards
• Develop and maintain project charters, scope statements, execution plans, budgets, and master schedules across multiple simultaneous capital initiatives.
• Provide technical oversight of civil, structural, mechanical, electrical, plumbing, HVAC, and process piping systems within GMP facilities, including cleanrooms, HVAC cascade design, CIP/SIP systems, and utility distribution.
• Commercial Manufacturing Facility and Lab Development/Design
• Review and Approve engineering deliverables including equipment submittals, P&IDs, and equipment layouts prior to installation and commissioning
• Ensure designs, material, personnel, process, and product flows comply with latest Global cGMP requirements
• Develop and execute commissioning plan as part of the facility lifecycle prior to validation activities
• Coordinate all construction activities with the internal departments to ensure no interruptions to ongoing processes
• Collaborate effectively with cross-functional departments in order to meet company expectations.
• Mentor, coach, train engineers on engineering practices, policies and requirements to support GMP operations.
• Troubleshoot and coordinate investigations of manufacturing and laboratory processes when needed.
• Assist with vendor communications and maintenance/repair scheduling by placing work orders
• Collaborate with clients, contract manufacturers, and vendors to meet project and company objectives.
• Lead engineering design reviews as needed.
• Participate in audits and regulatory agency inspections, as needed.
• Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities

Education & Experience

• Bachelor’s degree in engineering or a related field with 5+ years of relevant experience is required.
• 3+ years of experience with Capex project is required.
• Experience and ability to effectively support operations in a GMP manufacturing environment is required.
• Experience and ability to provide engineering leadership for both small projects and expansion capital projects is required.
• Experience with equipment/process troubleshooting and repair is required.
• Experience with facility and equipment commissioning and validation is required.
• Experience working with a Pharmaceutical or Biotechnology organization is preferred.
• Must possess and maintenance of a current valid driver’s license is required

Knowledge, Skills, & Abilities

• Knowledge of engineering principles required to support GMP facilities and equipment.
• Skilled at preparing technical reports, analysis, presentations to reflecting the status and results of projects in progress on a regular basis.
• Proficiency with commissioning, IQ/OQ/PQs for GMP equipment and facilities.
• 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
• Excellent interpersonal skills and ability to work well in a team environment.
• Excellent technical writing, communication and organizational skills.

Working Environment / Physical Environment

• This position works on site,
• Regular work schedule is Monday – Friday, within standard business hours.  Flexibility is available with manager approval.
• This position will have access to a lab environment.
• Ability to reach, bend, stoop, push and/or pull, and frequently lift up to 35 pounds and occasionally lift/move 50 pounds
• Ability to stand for extended periods of time while wearing appropriate clean room gowning material and appropriate personal protective equipment.
• Ability to work weekends occasionally to support the dynamic production schedule and relevant timelines.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.

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.

$141,000 (entry-level qualifications) to $155,000 (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.