Senior Project Engineer

Job Responsibilities

• Lead capital projects involving installation, upgrade, and optimization of equipment.
• Manage full project lifecycle including scope development, engineering design, procurement, installation, commissioning, and validation.
• Perform advanced process engineering analysis to select appropriate equipment technologies and improve manufacturing processes.
• Prepare capital project requests including cost estimates, schedules, technical justification, and ROI analysis.
• Manage project controls including forecasting, budget tracking, and schedule management.
• Evaluate and implement process control systems, monitoring technologies, and data acquisition systems.
• Lead development and execution of validation master plans and IQ/OQ/PQ protocols for equipment, facilities, and processes.
• Develop and maintain engineering documentation including URS, commissioning protocols, SOPs, work instructions, PM programs, and training materials.
• Assess equipment and facility modifications for regulatory impact and revalidation requirements.
• Support R&D scale-up activities and manufacturing process improvements.
• Cook up coordination with production, quality, validation, and maintenance teams to support project implementation.
• Provide technical leadership and mentorship to junior engineers.
• Ensure compliance with GMP, safety, and regulatory standards.
• Perform other duties as assigned.

Qualifications

• Education: B.S. degree in Engineering (Chemical, Mechanical, Industrial, or related field)
• Knowledge, Skills And Abilities:
  • Strong knowledge of Current Good Manufacturing Practices (cGMPs), FDA regulations, and pharmaceutical or regulated manufacturing environments.
  • Advanced knowledge of capital project management, process engineering, and manufacturing systems.
  • Experience with process control systems, automation, and data acquisition technologies.
  • Strong technical writing skills for engineering documentation and regulatory submissions.
  • Ability to read, analyze, and interpret scientific and technical journals, financial reports, and regulatory documentation.
  • Ability to present complex technical information to senior leadership and cross-functional teams.
  • Advanced analytical and statistical problem-solving capabilities including:
    • Design of Experiments (DOE)
    • Reliability Centered Maintenance (RCM)
    • Statistical analysis and variance analysis
    • Sampling theory and correlation analysis
  • Strong leadership, project management, and organizational skills.
  • Ability to manage multiple projects simultaneously in a fast-paced manufacturing environment.
• Experience: Minimum 10–15 years of engineering experience in manufacturing, pharmaceutical, chemical, or related regulated industries.