Equipment Engineer

The Equipment Engineer is responsible for the engineering support of process and utility equipment supporting installation and qualification of manufacturing equipment. The Equipment Engineer will provide support to site maintenance personnel during equipment troubleshooting. The Equipment Engineer will provide expertise in maintaining, designing, and improving all site equipment adhering to all site quality and safety requirements, and good engineering practices. The Equipment Engineer will serve as a project leader/manager for various cost improvement and capital funded projects.

The Equipment Engineer will interface with various outside contractors supporting the site in terms of equipment maintenance, or project execution.

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• Adhere to all safety standards and programs to ensure a safe work environment is achieved for all site personnel, and external contractors.
• Adhere to all quality standards and GMP requirements.
• Support the daily operation of all site process and utility equipment by performing routine walkthroughs, communicating with customers and maintenance technicians, monitoring established performance indicators.
• Equipment includes, but is not limited to, aseptic formulation and filling equipment, steam autoclaves, lyophilizer, RO and WFI production and distribution, clean steam production and distribution, steam boilers, chillers, air handlers
• Establish key performance indicators for equipment to visibly demonstrate efficient operations and to identify when equipment needs attention.
• Partner with maintenance staff to identify recommended routine maintenance required to keep equipment in working order and in approved validated state.
• Partner with maintenance staff to troubleshoot and resolve critical equipment issues.
• Partner with Quality and Validation personnel to assess impact of all unplanned maintenance work performed with respect to qualified parameters or processes.
• Actively monitor all equipment related metrics and prepare routine reports regarding the health and performance of the site equipment.
• Provide project management to small- and medium-sized projects (up to $500,000 range) including project economic evaluation and justification, cost estimation, project scope development, Capital Asset Request package preparation, equipment specifications, bid evaluation and project schedule.
• Plan, schedule, and coordinate all continuous improvement activities for semi-annual production shutdown events.
• Coordinate and supervise project-related construction activities, ensuring all external contractors adhere to and follow all site safety protocols.
• Develop clear communication plans regarding non-routine work impacting site personnel.
• Support maintenance personnel in creation/maintenance of equipment documentation (spare parts, manuals, PM and calibration tasks, troubleshooting guides).
• Establish and maintain continuous improvement programs with production, quality, and technical personnel to meet current regulatory compliance demands, reduce costs and improve productivity.
• Execute all tasks within established budgetary constraints.
• Will be required to perform other duties as requested, directed or assigned.
• Travel to fabrication facilities and plant sites to analyze equipment, collect data and information, interact with plant and fabricator personnel, perform on-site inspections, and gain experience valuable to design considerations (i.e., operating conditions, temperature considerations, etc.).
• Travel on business trips and/or field assignments as required to carry out departmental, project, and corporate tasks and functions.
• Write Requisition s, Specifications, Quality Documents, Operation and Maintenance Manuals, and other technical documents as required to carry out departmental tasks and functions.
• Provide support to the Sales and Estimating groups for the preparation of proposals, including sizing and selection of equipment, plant layout, and engineering man-hour estimates.

• Bachelor's degree in Engineering or related field.
• Must have excellent communication skills and ability/flexibility to work in a fast-paced environment.
• Project management experience
• Ability to establish & maintain effective working relationships.
• Basic computer experience a plus - Microsoft Office-Outlook/Word/Excel.
• Advanced computer skills including use of Microsoft Office.
• Basic use of Autodesk products or equivalent software.
• Excellent base of mechanical engineering technical skills, knowledge of processes, and the application of sound engineering practices.
• Utilize mechanical engineering principles for complex problem solving.
• Provide technical advisory services for field erection, commissioning, and plant shut down activities.
• Knowledge and understanding of materials including special alloys, material selection, and their use in mechanical equipment design.
• Application of ASME Codes and Standards, specifically ASME Section VIII and IX.
• Advanced knowledge and understanding of fabrication, welding, and…