Utilities SME

4 weeks ago

Sanford NC, United States Insight Global Full time

Qualifications: Bachelor's Degree in Engineering or related field 15+ years of experience in pharmaceutical manufacturing Direct knowledge and extensive experience in project management and regulated utilities (RO, WFI, clean steam, compressed gases, etc.) Experience with FDA and EU licensing and inspection Pluses: Experience in both Global Engineering and site level engineering Professional Engineer or Certified Project Management certification Familiarity with manufacturing and/or utilities equipment and operations Role Summary Insight Global is seeking a Senior Utilities Engineer in the Sanford, NC area, The Utilities SME is responsible for providing technical and engineering expertise to maximize site equipment availability, reliability and reduce maintenance costs through system and process continuous improvement, i.e., LEAN principles and Continuous Improvement methodology. Develop and implement strategies and methods that improve preventive maintenance processes and procedures resulting in enhanced equipment performance. Technically support all aspects of maintenance operations while ensuring compliance with SOPs, cGMPs, safety procedures, quality standards, OSHA standards, other regulatory agency standards, good maintenance practices, and corporate initiatives. A summary of responsibilities is as follows: Engineering SME responsible for regulated utility (Clean Steam, WFI and Compressed Gas) generation and distribution. Work closely with manufacturing personnel/other departments to resolve manufacturing issues and implement process improvements. Act as a liaison between maintenance and manufacturing personnel for corrective work and utilities support. Support implementation of process equipment upgrades and optimization. Capital projects for new bioprocess equipment purchase, installation and facility integration. Trouble shooting issues with utility support of process equipment. Coordination with other plant engineers, validation and automation colleagues in support of manufacturing operations. Responsibilities: Provide technical support for equipment and process improvement initiatives using good engineering practices, simple & advanced problem-solving techniques. Foster a Safety Culture Experience with Pharmaceutical clean room design and requirements Experience with regulated utility (RO, WFI, clean steam, compressed gases, etc.) generation and distribution Subject matter expert for adherence to all regulatory requirements pertaining to regulated utilities. Fully Accountable for all assigned area Infrastructure Assets. Plan and Forecast work required for assigned area Infrastructure Assets. Provide good judgment and innovation by utilizing and adapting a broad knowledge of engineering principles and practices acquired through progressive experience. Remain current in requirements of the ever-changing business environment inclusive of site/network plan of record, capital budgeting and total cost of ownership including reliability. Preparation of Capital Investment requirements to maintain assigned area's Asset Reliability and Plan of Record.

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