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Job Description
C&Q Lead at i-Pharm GxP C&Q Lead at i-Pharm GxP in Lebanon, Indiana Posted in 4 days ago.
Type:
full-time
Job Description:
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
