Senior Engineering Project Manager, GMP Pharma Manufacturing

U473 (FCRS = US473) Novartis Innovative Technologies Inc; North Carolina; On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis is seeking a Sr. Project Manager, Engineering to lead a portfolio of capital projects in a regulated manufacturing environment. You will guide teams through ambiguity, partner with site leadership, and balance cost, quality, and schedule to deliver innovative therapies worldwide.

The role emphasizes operational excellence, strong technical writing, and cross-functional collaboration across engineering and manufacturing. Onsite work in a regulated facility is required.

Qualifications

• Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering or related field.
• Nine years in pharmaceutical/biopharmaceutical manufacturing in regulated environments.
• Experience leading FDA-regulated and GMP-compliant projects.
• Strong knowledge of FDA regulations and GMP systems.
• Experience with capital improvement projects and process/layout development.
• Experience with GMP construction in brownfield or renovation environments.
• Knowledge of Quality by Design and Six Sigma methodologies.
• Excellent written and verbal communication skills.

Responsibilities

• Lead multiple capital projects from initiation through close-out, ensuring on-time, on-budget delivery.
• Act as primary client contact, managing stakeholder expectations and relationships.
• Manage project scope, schedule, and budget changes with clear impact assessments and approvals.
• Oversee contractors and internal teams for safe, compliant project execution.
• Resolve issues, risks, and resource constraints with site leadership.
• Prepare and manage budgets, forecasts, and funding documentation.
• Develop project objectives aligned with business plans and user requirements.
• Coordinate planning and scheduling across project teams and manufacturing operations.
• Communicate project performance, risks, and mitigations to site and senior leadership.
• Capture lessons learned and drive continuous improvement initiatives.

Skills

Project management

Stakeholder management

Regulatory compliance

Quality by Design

Six Sigma

Operational excellence

Problem solving

Budget planning

Technical writing

Team leadership

Education

Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering

Job description

Novartis is seeking a Sr. Project Manager, Engineering to lead a portfolio of capital projects in a regulated manufacturing environment. You will guide teams through ambiguity, partner with site leadership, and balance cost, quality, and schedule to deliver innovative therapies worldwide.

The role emphasizes operational excellence, strong technical writing, and cross-functional collaboration across engineering and manufacturing. Onsite work in a regulated facility is required.