Manager, Engineering - Capex Projects

ImmunityBio, Inc.•El Segundo, CA

1d•Onsite

About The Position

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.

Requirements

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.
Must possess and maintenance of a current valid driver’s license is required
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.

Nice To Haves

Experience working with a Pharmaceutical or Biotechnology organization is preferred.

Responsibilities

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

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