Senior Project Engineer

Provide engineering, project management, manufacturing and maintenance support to the GMP manufacturing site.  Ability to troubleshoot, problem solve and implement engineering solutions for existing manufacturing processes and equipment.  Direct, evaluate and assist capital engineering and process improvement projects.  Design, procure and commission new process and utility equipment and upgrades to existing systems.    

Responsibilities

• Managing mid-to-large sized engineering projects by planning and tracking activities of cross-functional teams and contractors.
• Develop schedules and performance requirements using appropriate verification tools and techniques to manage project scope, schedule and cost ensuring that project goals are met on time and within budget.
• Analyze resources and priorities to be applied to assigned projects and perform risk management activities to minimize project risks.
• Develop and execute commissioning plans to ensure that process and utility systems and equipment are suitable for their intended use
• Develop and review process flow diagrams and piping and instrumentation drawings (P&IDs) for new process and utility systems and modifications to existing systems
• Direct and or assist in the design and execution of all capital projects assigned
• Support engineering development with load calculations of flow, heating/cooling capacity, pressures, etc.
• Utilize strong technical writing skills to prepare engineering evaluations, change control documentation, testing plans, corrective and preventive actions (CAPAs)
• Lead and assist in investigations of process systems and equipment to determine and document root cause and ensure the appropriate corrective actions are initiated and implemented
• Use statistical tools in analyzing data to predict trends, measure process capability, improve operating procedures or preventative maintenance procedures, identify bottle necks and equipment reliability
• Help develop efficient PM plans for all key pieces of manufacturing and utilities equipment and provide troubleshooting expertise in all areas of plan operations and maintenance.
• Serve as the technical liaison for all OSHA, regulatory and other audits that relate to the maintenance/facility aspects of the manufacturing facility
• Assist in writing regulatory documents for FDA submissions as required
• Create capital expenditure requests and purchase requisitions for approvals prior to procurement of process and utility systems and equipment

Qualifications

• Bachelor's degree in Mechanical, Biochemical, or Chemical Engineering.
• Minimum of 10 years of engineering experience in a cGMP Pharmaceutical/Biological manufacturing environment.
• Able to coordinate and complete complex projects.
• Excellent written and oral communication and presentation skills.
• Computer literate in word processing and data entry.
• Extensive experience with MS Project or Smartsheets, AutoCAD and maintenance planning/scheduling related software.
• Excellent problem-solving skills, detail oriented, and excellent mechanical aptitude, mathematical and statistical analysis skills.