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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.

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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

A minimum of a BS degree + 15 years of experience; MS + 10 years of experience; PhD degree + 6 years of experience in any of the following disciplines: Construction Management, Biotechnology, Chemical Engineering, Mechanical Engineering, or equivalent science or engineering related discipline.

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