C&Q Node Lead

We are seeking an experienced C&Q Node Lead to support a large-scale, multi-year pharmaceutical manufacturing facility project. This leadership role is responsible for driving commissioning and qualification activities within a critical project node while ensuring alignment with overall program objectives. The individual will oversee execution, compliance, planning, operational readiness, and stakeholder coordination throughout the project lifecycle. This position offers significant visibility, leadership responsibility, and the opportunity to build and lead teams as the program expands. The role requires strong expertise in GMP-regulated environments and end-to-end commissioning and qualification processes., * Mechanical Completion (MC)

• Pre-Commissioning Activities
• Utility Startup and System Priming
• Instrument Calibration
• Automation System Downloads
• Consumable Installation
• Variable Frequency Drive (VFD) Setup
• Operational Readiness
• Startup Support
• Utilities Coordination
• Temporary Power Management
• Wastewater and Drainage Capacity Planning
• Lockout/Tagout (LOTO)
• Continuous Improvement
• Punch List Management
• Safety Leadership

Do you have experience in Team development?, * Commissioning & Qualification (C&Q)

• GMP Compliance
• Pharmaceutical Manufacturing
• Biotech Environment
• FDA-Regulated Environment
• C&Q Lifecycle Management
• Program Leadership
• Team Building and Leadership
• Program Coordination
• KPI Tracking and Reporting
• Risk Management
• Critical Path Analysis
• Schedule Planning
• Change Management, * Experience within pharmaceutical, biotech, or FDA-regulated environments
• Strong knowledge of GMP and commissioning & qualification processes
• Experience across the full commissioning and qualification lifecycle
• Proven ability to build, develop, and lead teams
• Experience serving as a primary point of contact for program leadership
• Experience coordinating cross-functional project teams
• Ability to support system handover to operations and end-user teams
• Experience managing commissioning and qualification schedules, risks, and milestones

Additional Skills

• Experience leading commissioning and qualification efforts on large-scale CAPEX projects
• Experience supporting greenfield projects
• Experience supporting brownfield projects
• Background supporting complex manufacturing systems
• Background supporting utilities systems
• Experience driving operational readiness initiatives
• Experience implementing continuous improvement programs
• Strong understanding of regulatory and quality requirements
• Experience managing project closeout activities
• Strong commitment to safety culture and site safety standards