The Plant Engineer IV provides hands on support throughout the various manufacturing facilities in areas such as process equipment improvements, technological advancements, capital projects, existing manufacturing equipment, cost improvements, facility maintenance, safety, and environmental regulation.
Requirements
- Author user requirements for equipment, instrumentation, and other activities and create standard operating procedures in alignment with broader operational strategies.
- Provide technical training to appropriate personnel including but not limited to Plant Engineers, Facility Technicians, Operations personnel, and Validation personnel.
- Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems.
- Lead major projects and tracking spending of budgets, creating scope of work, risk assessments, justification, cost estimates, implementing purchase order requisitions, contracts, funding requests, and controlling their payment.
- Establish and streamline/innovate practices around equipment and/or facility specification, design, start-up, and commissioning & qualification
- Provide Technical input for Architectural features, Structural/Civil, Biotech process and laboratory equipment and systems, HVAC, Plant and Clean Utility Systems, Electrical Power and Lighting, Automation.
- Design and execution of engineering runs to test equipment or to troubleshoot problems.
- Work with end users to develop system requirements, specification of equipment/buildings, support fabrication and perform Factory/Site Acceptance Testing.
- Support Manufacturing, Maintenance and Facilities functions for multiple locations including corrective and preventative maintenance and repair of facilities, utilities, and equipment.
- Prepare URS, ETOPs, Risk Assessments, Safety Assessments and other good engineering documents associated with the Facilities, Systems, Utilities and Equipment (FSUE) as required.
- Work closely with other support groups such as MTS, Automation, Manufacturing, Quality Assurance, Facility Operations and Maintenance/Metrology, Engineering, EHS&S, and Quality Control to ensure that PCI assets are well engineered and maintained throughout their lifecycles.
- Procure new equipment, create, and maintain the appropriate engineering records including equipment records and manuals, drawings and diagrams, inspection reports per Good Engineering policies.
- Support the execution of start-up and commissioning activities on Equipment, utility and GMP manufacturing Facilities, Systems, Utilities and Equipment.
- Champion safety in design and operation of the facility and systems.
