Project Manager, Operational Readiness (pharma)

Qualifications:

• Bachelor’s Degree in Engineering, a related technical discipline, or an equivalent combination of education and experience.
• Advanced project management competencies developed through formal PM training or relevant experience preferred.
• 5 years of engineering experience involving facility infrastructure and pharmaceutical manufacturing preferred.
• 5 years of project or portfolio management experience supporting major capital projects preferred.
• Experience managing multiple projects and cross-functional workstreams simultaneously.
• Greenfield startup or operational readiness experience strongly preferred.
• Pharmaceutical manufacturing or other relevant regulated manufacturing experience preferred.
• Working knowledge of building and utility equipment.
• Ability to read and review CAD drawings with a basic understanding of P&IDs, HVAC, and electrical systems.
• Understanding of product documentation and SOPs within a structured manufacturing environment.
• Experience developing detailed project schedules and work plans.
• Strong understanding of schedule, risk, budget, resources, change control, and overall project execution.
• Strong stakeholder management, negotiation, conflict-management, problem-solving, and communication skills.
• Demonstrated ability to lead and influence cross-functional teams without losing alignment across parallel workstreams.

Job Description:

We are seeking an experienced Project Manager to support Greenfield Operations and Site-Wide Readiness for a Fill Finish Expansions program in Clayton, NC. The role will help prepare a new pharmaceutical manufacturing facility for operational startup. The Project Manager will coordinate across multiple work packages and functional teams, identify gaps that could impact operational readiness, establish remediation plans and ownership, and drive activities through delivery and into operations. Site-wide readiness activities include document control, metrology, preventative maintenance, environmental monitoring, spare parts, and other functions required to bring the facility online.

Key Responsibilities:

• Manage site-wide operational readiness activities across multiple work packages and functional teams.
• Identify, map, and assess gaps between project workstreams and develop remediation plans, ownership, milestones, and schedules.
• Coordinate across IT systems, facilities, clean utilities, warehouse, construction, and GxP operations during construction.
• Develop detailed project plans, business cases, schedules, milestones, and leadership-level project updates.
• Manage stakeholder alignment between central teams, the local site, vendors, work packages, and functional groups.
• Track project risks and drive mitigation, intervention, and problem-solving activities.
• Support readiness for the installation, troubleshooting, qualification, and validation of buildings and equipment.
• Lead and manage capital project execution in accordance with established policies and procedures.
• Coordinate with external design firms on equipment and building projects from conceptual design through execution.
• Manage major milestones, schedules, and monthly cost plans through the Clarity PEM process.
• Manage project change control to maintain alignment with defined scope, budget, and schedule.
• Track project performance, metrics, and KPIs while providing regular updates to leadership.
• Collaborate across the Novo Nordisk network to apply applicable best practices and specifications to the Clayton site.
• Support training requirements for personnel involved in project execution and operational readiness.