Project Engineer (Lebanon, IN) Onsite Position Summary The Project Engineer will support the Project Manager in delivering design, construction, commissioning, qualification (C&Q), and site activities for a new biopharmaceutical drug product manufacturing site in Lebanon, IN. This hybrid role requires on-site presence at least three days per week and offers a one-year contract with potential for extension. Roles and Responsibilities Participate in sourcing, scheduling, planning, construction, and tracking of process equipment activities. Lead change management efforts related to process equipment with cross-functional teams. Track procurement progress and ensure timely delivery of construction materials and equipment. Participate in Factory Acceptance Testing (FAT) to verify equipment specifications. Coordinate equipment arrivals and logistics with construction teams. Support Site Acceptance Testing (SAT), commissioning, and qualification activities. Conduct equipment risk management and implement mitigation strategies. Manage Requests for Information (RFIs) and ensure timely responses. Track field progress and update bi-weekly progress curves. Support project closeout and seamless turnover of manufacturing capacity. Collaborate with internal and external stakeholders including engineering, consultants, contractors, vendors, automation, and validation teams. Qualifications Minimum 10 years of experience in large-scale capital projects for pharmaceutical manufacturing. Expertise in process equipment design, specification, and validation (e.g., reactors, centrifuges, filtration systems, CIP/SIP). Proficiency with PFDs, P&IDs, and equipment layout. Familiarity with automation systems (PLC/SCADA), utilities, and HVAC in cleanroom environments. Experience managing projects from concept through procurement, construction, C&Q, and turnover. Skilled in budgeting, scheduling (MS Project, Primavera), risk management, and quality control. Strong communication, leadership, and decision-making abilities. CPM scheduling skills and attention to detail. Demonstrated integrity, ownership, and goal-oriented mindset. Additional Preferences Bachelor's degree in Chemical, Mechanical, Biochemical Engineering, or related field. Experience in mega capital project delivery. Knowledge of GMP, FDA regulations, and ICH guidelines. Understanding of equipment qualification (IQ/OQ/PQ) and process validation. Experience supporting regulatory inspections and audits (FDA, EMA, etc.). OSHA 30 certification. Job description : Location Marysville, OHIO Key Responsibilities: Develop and modify Yaskawa robot programs based on project specs. Diagnose and troubleshoot robotic issues. Collaborate with engineering and production for system integration. Perform system testing and validation. Provide technical support and training to team members. Maintain documentation for robotic systems and programming changes.
Job ID: 490604737
Originally Posted on: 8/24/2025
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