Project Engineer(Medical/Pharma) Lebanon, IN Onsite

Title: Project Engineer

Location: Lebanon, IN | Onsite

Duration: 6-12+ Months

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.

Best regards,

Lavesh Kumar

| Sr. Technical Recruiter

STELLENT IT A Nationally Recognized Minority
Certified Enterprise

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