Sr. Project Engineer

• Bachelor’s degree in Mechanical, Biochemical, or Chemical Engineering.
• Minimum of 10 years of engineering experience in a cGMP Food/Pharmaceutical/Biological manufacturing environment.

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