Job Description

Role Summary

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.
• Perform equipment evaluations to determine and justify new equipment, equipment replacement and incorporate into capital plan. Equipment replacement should be identified as part of a site or facility Master Plan.
• Review equipment for condition, performance, and maintenance history; assessing the liability caused by marginal equipment performance; assessing the cost and value of overhauling or upgrading to the cost of replacement; and creating justifications for capital replacements.
• Equipment evaluations should include risk assessments to determine if adequate redundancy exists to support operations in the event of catastrophic equipment failure.
• Recommends and presents capital equipment purchases to facilitate campus growth and to maximize equipment reliability.
• Provide subject matter expertise for PM task-list development and revisions. Assists RCM analysis team to determine PM and part strategies. Based on expertise, history, and RCM analysis results.

Qualifications

• A minimum of a BS degree + 15 years of relevant experience
• Direct knowledge and extensive experience in project management and regulated utilities (RO, WFI, clean steam, compressed gases, etc.) within a biopharmaceutical or pharmaceutical cGMP environment is required. Professional Engineer or Certified Project Management certification preferred. Experience with FDA and EU licensing and inspection is beneficial. Familiarity with manufacturing and/or utilities equipment and operations is desired.
• Experience in both Global Engineering and site level engineering is strongly preferred

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