Job Title: Commissioning & Qualification (C&Q) Node Lead

We are seeking a highly motivated C&Q Node Lead to play a critical role in driving commissioning and qualification activities within a large-scale program. This position serves as the primary point of contact for the C&Q Program Lead, ensuring efficient execution, regulatory compliance, and on-time project delivery.

Location: Boone County, IN (relocation candidates accepted!)

Pay: $100 - $125/hr

Duration: 2+ year Contract (12 Months + extensions to start)

Key Responsibilities

• Serve as the primary point of contact for the C&Q Program Lead within the assigned node.
• Develop and execute comprehensive commissioning & qualification (C&Q) strategies, plans, and schedules aligned with program objectives.
• Ensure strict adherence to C&Q procedures, regulatory requirements, and program standards.
• Identify and implement opportunities to improve processes, drive efficiency, and maintain compliance across the node.
• Provide regular updates to leadership on progress, risks, and key issues related to C&Q activities.

Execution & Coordination

• Coordinate Factory Acceptance Tests (FATs) with vendors and contract manufacturers.
• Lead and support day-to-day C&Q operations within the node.
• Review and approve Mechanical Completion (MC) packages from C&Q firms.
• Coordinate and participate in operational readiness initiatives.

Pre-Commissioning Activities

Assist in coordinating and overseeing key pre-commissioning activities, including:

• Utility priming
• Instrument calibration
• Automation system downloads
• Installation of consumables (e.g., filter cartridges)
• Variable Frequency Drive (VFD) setup
• Punch list closeout in collaboration with C&Q firms and SWAT teams

Cross-Functional Collaboration

• Partner with other C&Q Node Leads to coordinate:
  • Utility demand (steam, water, temporary power, etc.)
  • Wastewater discharge and system loading
• Collaborate with mechanical teams to support Lockout/Tagout (LOTO) processes
• Support and/or lead system turnover and handover to end users

Reporting & Metrics

Provide structured reporting to the C&Q Program Lead, including:

• Change management tracking (scope changes)
• Progress metrics and performance tracking
• 2-4 week look-ahead planning
• Critical path analysis
• Resource planning and allocation

Safety Leadership

• Champion a strong safety culture by ensuring all activities meet site safety standards and industry best practices
• Promote a safe, compliant, and proactive working environment for all team members

What We're Looking For

• Strong experience in commissioning & qualification within regulated industries (pharmaceutical, biotech, or similar)
• Proven ability to manage complex projects and cross-functional teams
• Excellent communication, planning, and problem-solving skills
• Deep understanding of GxP compliance and safety standards