Manager, Engineering - Capex Projects
ImmunityBio, Inc.
2 hours ago
On-site
El Segundo, CA
Operations
Position Summary
Manager, Engineering—Capex Projects: Provide leadership overseeing planning, execution, and delivery of capital construction projects in GMP-regulated environments as the primary technical authority and project owner for commercial construction.
Essential Functions / Responsibilities
- Lead major Capex projects (concept, RFP, buildout, commissioning, handover); manage plans, budgets, schedules, and vendors.
- Manage contractors/engineers to install to ImmunityBio standards.
- Create/manage project charters, scope, execution plans, budgets, and master schedules across multiple initiatives.
- Provide technical oversight for GMP facility systems (civil/structural, mechanical, electrical, plumbing, HVAC, process piping; cleanrooms; HVAC cascade; CIP/SIP; utility distribution).
- Review/approve engineering deliverables (submittals, P&IDs, equipment layouts); ensure compliance with global cGMP.
- Develop/execute commissioning plans; coordinate construction to avoid interruptions to ongoing manufacturing.
- Mentor engineers; troubleshoot and coordinate investigations; manage vendor communications/work orders.
- Lead design reviews; participate in audits/regulatory inspections; develop/maintain SOPs and templates.
Qualifications
- Bachelor’s degree in engineering or related field + 5+ years relevant experience (required).
- 3+ years Capex project experience (required).
- GMP manufacturing operations experience (required); engineering leadership for small/expansion projects (required).
- Equipment/process troubleshooting/repair; commissioning and validation experience (required).
- Pharmaceutical/biotech experience preferred.
- Valid driver’s license required.
Skills/Abilities
- Commissioning (IQ/OQ/PQ), quality systems knowledge (change control, CAPA, deviations/OOS, training/document control).
- Working knowledge of GMP, OSHA, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing.
- Strong technical reporting, writing, communication, and organizational skills.
Benefits (eligible employees)
- Medical, dental, vision; EAP; life/AD&D, short/long-term disability; healthcare/dependent care FSAs; 401(k) match; 529; PTO (11 holidays) and other PTO terms.
Application instruction
- Application window closes ~60 days from posting (or sooner if filled/closed).
Manager, Engineering—Capex Projects: Provide leadership overseeing planning, execution, and delivery of capital construction projects in GMP-regulated environments as the primary technical authority and project owner for commercial construction.
Essential Functions / Responsibilities
- Lead major Capex projects (concept, RFP, buildout, commissioning, handover); manage plans, budgets, schedules, and vendors.
- Manage contractors/engineers to install to ImmunityBio standards.
- Create/manage project charters, scope, execution plans, budgets, and master schedules across multiple initiatives.
- Provide technical oversight for GMP facility systems (civil/structural, mechanical, electrical, plumbing, HVAC, process piping; cleanrooms; HVAC cascade; CIP/SIP; utility distribution).
- Review/approve engineering deliverables (submittals, P&IDs, equipment layouts); ensure compliance with global cGMP.
- Develop/execute commissioning plans; coordinate construction to avoid interruptions to ongoing manufacturing.
- Mentor engineers; troubleshoot and coordinate investigations; manage vendor communications/work orders.
- Lead design reviews; participate in audits/regulatory inspections; develop/maintain SOPs and templates.
Qualifications
- Bachelor’s degree in engineering or related field + 5+ years relevant experience (required).
- 3+ years Capex project experience (required).
- GMP manufacturing operations experience (required); engineering leadership for small/expansion projects (required).
- Equipment/process troubleshooting/repair; commissioning and validation experience (required).
- Pharmaceutical/biotech experience preferred.
- Valid driver’s license required.
Skills/Abilities
- Commissioning (IQ/OQ/PQ), quality systems knowledge (change control, CAPA, deviations/OOS, training/document control).
- Working knowledge of GMP, OSHA, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing.
- Strong technical reporting, writing, communication, and organizational skills.
Benefits (eligible employees)
- Medical, dental, vision; EAP; life/AD&D, short/long-term disability; healthcare/dependent care FSAs; 401(k) match; 529; PTO (11 holidays) and other PTO terms.
Application instruction
- Application window closes ~60 days from posting (or sooner if filled/closed).