Morgan Smith, P.E. Email and Phone Number

· Responsible for the Design and Engineering (D&E) function associated with capital and major maintenance project support at storage, production, gate station, transmission system facilities.· Manage capital and maintenance projects of moderate and major scope (~$100k - $5M), including preliminary engineering design, financial planning, scheduling, equipment specification and procurement, contractor interfacing, construction and operating drawings, commissioning and operating procedures, and project documentation.· Develop process flow-sheets, control loop, piping and instrumentation diagrams (P&ID), construction drawings, etc. · Perform engineering analysis and equipment specification and selection (filter/separator vessels, line heaters, meters, isolation valves, etc.), piping design, control valve and regulator sizing, corrosion/cathodic protection, etc. on projects varying in size and scope. · Scope of design work includes mechanical (stress analysis, thermodynamics, fluid mechanics/hydraulic analysis, etc.), electrical & instrumentation, etc. as well as interfacing with other internal engineering disciplines and subject matter experts (corrosion engineering, materials engineering, civil engineering, etc.) · Utilize numerous design codes and regulations such as DOT 49 CFR Part 192, ASME Boiler & Pressure Vessel Code Section VIII Division I, ASME B31.3, ASME B31.1, ASME B31.8, etc.· Develop and update piping and equipment standards and specifications. · Assist with management of a formal equipment testing program including evaluating capacity ratings of equipment (pumps, etc.), recommendations for maintenance, post-maintenance evaluation, etc. · Assist with troubleshooting mechanical/electrical equipment and make recommendations for repair or replacement, as required. · Support Corporate Strategy to develop renewable energy opportunities including developing interconnect facility design.

- Ensure that equipment, processes, and systems used in pharmaceutical manufacturing and packaging operations comply with regulatory requirements and industry standards. Responsible for planning, executing, and documenting validation activities throughout the product lifecycle.- Collaborate with cross-functional teams to develop validation plans and strategies for new equipment, processes, and systems. Define validation protocols, test cases, and acceptance criteria.-Execute validation protocols, perform tests, collect data, and analyze results to ensure compliance with regulatory requirements and internal standards. This includes equipment qualification, process validation, and cleaning validation.- Conduct risk assessments to identify critical process parameters, potential failure modes, and associated risks. Develop mitigation strategies to minimize risks and ensure product quality and patient safety.- Prepare validation documentation, including protocols, reports, standard operating procedures (SOPs), and change controls. Ensure all documentation is accurate, complete, and compliant with regulatory guidelines.- Stay updated with relevant regulations, guidelines, and industry best practices related to validation and quality assurance. Ensure validation activities are conducted in accordance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).- Collaborate with various departments, such as Manufacturing, Quality Assurance, Regulatory Affairs, and Engineering, to ensure effective communication and coordination during validation activities. Participate in project teams to provide validation expertise and support.- Identify areas for process optimization and improvement within the validation function. Propose and implement corrective and preventive actions (CAPAs) to address deviations or non-compliance.- Provide training and guidance to support the development of junior validation engineers and technicians.

- Obtained field measurements to locate equipment for plant layout- Assisted in developing plans and procedures for new reactor- Created/Corrected/Updated/Plotted drawings using AutoCAD- Calculated pressure drops for proposed piping systems and pump design- Estimated cooling load for a HVAC units- Updated scope of work sheets and drawing lists- Collaborated with outside companies regarding equipment