C&Q Lead

Commissioning & Qualification (C&Q) Project Lead

12 - Month Contract Initially

Onsite - Lebanon, Indiana

Competitive Pay and $3500 Expenses Monthly

We are seeking an experienced Commissioning & Qualification (C&Q) Building Lead to support a major pharmaceutical manufacturing project. This individual will serve as the primary point of contact for the C&Q Program Lead and will be responsible for coordinating commissioning, qualification, operational readiness, and system handover activities within their assigned project node. The successful candidate will play a critical role in driving project execution, maintaining regulatory compliance, ensuring operational readiness, and supporting safe and efficient project delivery.

Key Responsibilities:

• Act as the primary liaison between the assigned project node and the C&Q Program Lead.
• Develop and implement commissioning and qualification strategies, execution plans, and schedules to support project milestones and regulatory requirements.
• Ensure compliance with established C&Q procedures, standards, and program strategies.
• Drive continuous improvement initiatives to enhance C&Q execution, efficiency, and compliance across the project.
• Provide regular updates to program leadership regarding project progress, risks, issues, and mitigation plans.
• Coordinate Factory Acceptance Tests (FATs) with equipment vendors and contract manufacturers.
• Oversee and coordinate day-to-day commissioning and qualification activities within the assigned node.
• Review and approve Mechanical Completion (MC) packages and acceptance documentation from C&Q contractors.
• Coordinate and participate in Operational Readiness activities.

Support and coordinate pre-commissioning activities including:

• Utility priming and startup.
• Instrument calibration
• Automation software downloads and configuration
• Installation of consumables and filter systems
• Variable Frequency Drive (VFD) setup and testing
• Coordinate punch list resolution activities with C&Q contractors and project SWAT teams.
• Interface with other C&Q Building Leads to ensure alignment and project integration.
• Coordinate utility demand planning, including temporary and permanent utilities such as steam, water, and compressed gases.
• Manage wastewater discharge requirements and loading on site drainage systems
• Support Lockout/Tagout (LOTO) coordination activities with mechanical and construction teams.
• Lead and support system turnover and handover activities to end users and operations teams

Track and report project metrics, including:

• Change management and scope control
• Progress tracking and KPI reporting
• Two-to-four-week look-ahead planning
• Critical path analysis
• Resource planning and forecasting
• Promote and enforce a strong safety culture, ensuring all commissioning and qualification activities are executed in accordance with site safety requirements and industry best practices.

Qualifications

• Extensive experience leading Commissioning & Qualification activities within pharmaceutical, biotechnology, or regulated manufacturing environments.
• Strong understanding of GMP, validation, commissioning, qualification, and operational readiness requirements.
• Experience coordinating FATs, Mechanical Completion, pre-commissioning, startup, and system handovers.
• Proven ability to manage multiple stakeholders, contractors, vendors, and cross-functional teams.
• Strong project management, planning, communication, and problem-solving skills.
• Experience working on large-scale capital projects is highly desirable.

Preferred Background

• Pharmaceutical, Biotech, Cell & Gene Therapy, Vaccine, Sterile Manufacturing, or API Facilities
• Greenfield and Brownfield project experience.

Experience supporting major facility expansions, new product introductions, or site start-up activities