Manager, Engineering - Capex Projects

Position Summary

The Manager, Engineering- Capex Projects is responsible for leading major capital construction projects within GMP regulated environments. This role involves overseeing project planning, execution, and delivery, ensuring compliance with regulatory standards, engineering specifications, cost targets, and schedule milestones.

Essential Functions

• Lead Major Capex projects from concept design, RFP, buildout, commissioning, and handover to users.
• 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.
• 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.
• Absorb and coordinate 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.

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.

Knowledge, Skills & Abilities

• Knowledge of engineering principles required to support GMP facilities and equipment.
• Skilled at preparing technical reports, analysis, presentations to reflect 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.