Project Engineering, Associate Director
Core
End-to-end execution of complex capital projects ($1MM–$50MM+) in a cGMP-regulated biopharmaceutical manufacturing environment, ensuring delivery aligned with business priorities and regulatory expectations.
Role type
Senior IC project engineering leader (capital projects)
Builds
Manufacturing capacity, capability, and compliance across production facilities
Domain
Biopharmaceutical manufacturing / Capital project engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic leadership across engineering disciplines, cGMP/ISPE compliance, capital project lifecycle management, risk and change control, stakeholder partnership, financial stewardship, team leadership, Lean Six Sigma principles
Preferred skills
Advanced degree (MS or MBA), PMP certification, Lean Six Sigma Green Belt or higher, Professional Engineer (PE) license
Technologies
PLC, SCADA, HVAC, WFI, clean steam, process gases
Responsibilities
Provide strategic and technical leadership across process, mechanical, electrical, automation, and facilities disciplines; Lead full lifecycle of capital projects from concept through commissioning and qualification; Ensure project activities meet global regulatory requirements (FDA, EMA) and quality standards; Manage capital expenditure budgets and drive cost efficiency; Lead, coach, and develop a high-performing team of project engineers; Champion safety-by-design principles and zero-harm safety culture
Seniority
Senior, hands-on IC with people leadership
