Position Overview
We are seeking an experienced Project Planner / Scheduler to support the development, integration, and execution of the site's startup and operational readiness schedules. This individual will be responsible for managing the Master Integrated Schedule (MIS) across multiple functional workstreams, ensuring alignment between engineering, CQV, manufacturing readiness, quality, supply chain, technical transfer, and operational teams.
The ideal candidate will have deep experience supporting large-scale biotech or pharmaceutical facility activations, strong expertise with Primavera P6 and Monday.com, and a thorough understanding of cGMP startup activities, technology transfer, validation, and manufacturing readiness programs.
Key Responsibilities
Master Integrated Schedule Management
- Develop, maintain, and continuously optimize the site-wide Master Integrated Schedule (MIS) utilizing Primavera P6 and Monday.com.
- Establish schedule governance, progress tracking methodologies, and milestone reporting processes.
- Ensure alignment between construction completion, CQV activities, technology transfer, operational readiness, and manufacturing startup timelines.
Schedule Integration & Interdependency Management
- Integrate workstream-level schedules into a consolidated program schedule.
- Build and maintain critical path logic, predecessor-successor relationships, and dependency mapping across functions.
- Coordinate with project managers, workstream leads, CQV teams, manufacturing, and quality stakeholders to ensure schedule accuracy and alignment.
Critical Path & Variance Analysis
- Conduct weekly critical path reviews and schedule health assessments.
- Identify schedule risks, bottlenecks, and potential delays before execution impact occurs.
- Perform schedule variance analysis and provide mitigation recommendations to project leadership.
- Generate rolling look-ahead schedules and executive reporting dashboards.
Capacity Planning & Resource Modeling
- Analyze labor, equipment, facility, and operational capacity requirements across startup activities.
- Support resource leveling and workload balancing for commissioning, qualification, validation, and batch execution campaigns.
- Develop forecasting models to identify upcoming resource constraints and capacity risks.
CQV, Quality & Regulatory Readiness Scheduling
- Coordinate schedules supporting commissioning, qualification, validation, and operational readiness initiatives.
- Align project milestones with Health Authority inspections, regulatory audits, and internal quality assessments.
- Partner with Quality, Validation, and Manufacturing teams to ensure readiness activities are executed according to plan.
Reporting & Stakeholder Communication
- Present schedule updates, key milestones, risk assessments, and recovery plans to project leadership.
- Develop executive-level reports, dashboards, and KPI tracking tools.
- Facilitate schedule review meetings and drive accountability across functional teams.
Required Qualifications
- Bachelor's Degree in Engineering, Construction Management, Life Sciences, Project Management, or a related technical discipline.
- 8+ years of project scheduling and planning experience supporting large-scale capital projects.
- Experience within biotech, pharmaceutical, life sciences, or highly regulated manufacturing environments.
- Proven experience supporting facility startup, commissioning, qualification, validation (CQV), operational readiness, or technology transfer programs.
- Experience managing integrated schedules for projects valued at $300M+.
- Proficiency in Primavera P6.
- Advanced experience with Monday.com.
- Experience integrating schedules with enterprise platforms such as SAP, MS Project, MES, Smartsheet, or similar systems.
- Strong understanding of Critical Path Method (CPM) scheduling principles.
- Advanced reporting, forecasting, and schedule analytics capabilities.
Preferred Qualifications
- PMI Scheduling Professional (PMI-SP) Certification.
- Primavera P6 Professional Certification.
- Prior experience supporting greenfield biotech manufacturing facility startups.
- Understanding of cGMP manufacturing environments, validation processes, and technology transfer programs.
Project Scheduler in Cary at Insight Global
This position is listed as full time and onsite. It was posted 4 days ago.