Senior Project Manager, Capital Projects
Listed on 2026-08-09
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Engineering
Regulatory Compliance Specialist, Quality Engineering
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Please note this is a Direct Hire Position for Novartis::
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!
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Senior Project Manager - Capital Projects, EngineeringJob Description Summary
Lead the planning, execution, delivery, and closeout of large-scale capital projects supporting the Durham Novartis Campus. This role provides end-to-end project leadership for complex GMP capital programs, including facility construction, equipment installation, automation integration, commissioning and qualification readiness, operational turnover, and project closeout. The role serves as the primary engineering project lead for major capital investments and partners across engineering, construction, procurement, quality, manufacturing, EHS, supply chain, finance, validation, automation, and external contractor organizations.
Key responsibilities:- Lead large, complex capital projects supporting sterile filling, packaging, and GMP manufacturing facility expansion.
- Manage capital projects from concept, business case development, front-end planning, design, procurement, construction, commissioning, qualification, operational readiness, turnover, and project closeout.
- Serve as the primary project leader and client-facing engineering representative for assigned large capital programs.
- Develop and maintain the project execution strategy, governance structure, objectives, scope, schedule, budget, risk profile, and performance metrics.
- Own project budget management, cost forecasting, cash flow, contingency planning, change control, and financial reporting for assigned capital programs.
- Lead schedule development and integration across design, procurement, construction, equipment delivery, installation, commissioning, qualification, operational readiness, and licensure-enabling activities.
- Provide leadership and oversight for architectural/engineering deliverables, construction execution, equipment layout, cleanroom facility interfaces, utilities, automation, process equipment, and GMP facility readiness.
- Ensure project execution is aligned with GMP requirements, sterile facility expectations, site standards, quality systems, EHS requirements, and applicable regulatory expectations.
- Lead cross-functional decision making to resolve project issues, resource constraints, design conflicts, construction barriers, procurement delays, quality concerns, and operational readiness gaps.
- Ensure disciplined project controls are used, including cost tracking, schedule controls, change management, risk registers, decision logs, action trackers, contingency management, lessons learned, and project closeout.
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Construction Management, Project Management, or a related technical field and 9 years of experience in pharmaceutical or biopharmaceutical GMP manufacturing operations.
- At least 9 years leading large capital projects in pharmaceutical, biotechnology, sterile manufacturing, aseptic filling, fill/finish, packaging, or related GMP-regulated manufacturing environments.
- Demonstrated experience managing multiple capital projects of approximately $50 - 400 million or greater from start to finish, including early planning, design, procurement, construction, commissioning, qualification, turnover, and closeout.
- Proven experience managing complex capital programs with significant facility, equipment, automation, utility, construction, validation, and operational readiness scope.
- Strong understanding of GMP requirements and experience providing project leadership in highly regulated pharmaceutical or biotechnology facilities.
- Experience with sterile manufacturing, aseptic processing, sterile filling, packaging operations, cleanroom environments, GMP utilities, and regulated facility construction.
- Strong experience managing architectural/engineering firms, construction management firms, general contractors, trade contractors, equipment suppliers, automation vendors, and technical consultants.
- Excell…
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