Sr. Utility Engineer
On-siteNew Albany, Ohio, United States
Job Summary
Lead capital projects by developing scope, budgets, and user requirements, then managing all phases from equipment reconfiguration to factory acceptance. Optimize utility systems through capacity analysis, preventive maintenance scheduling, and breakdown evaluation to increase equipment availability. Provide subject matter expertise for clean utilities, steam, power distribution, and cooling systems while developing metrics and troubleshooting mechanical issues in an aseptic manufacturing environment. Chair meetings, present to leadership, and ensure all procedures adhere to cGMP and FDA regulations across multiple Ohio locations.
Required Qualifications
- Bachelor's Degree in Engineering or equivalent years of related experience
- Minimum of 7 years of manufacturing facility engineering experience
- Minimum 4 years of experience with Clean Utility systems and equipment such as filters, ion exchange, Reverse Osmosis, multi-effect stills, clean steam generators, etc.
- Experience with Plant Utility systems and equipment such as vacuum pumps, compressors, chillers, boilers, etc.
- Experience with HVAC systems such as air handlers, chillers, heat exchangers
- Ability to size and specify Utility equipment
- Experience with coordinating large scale shutdown/turnarounds
- Ability to understand mechanical layouts and electrical/pneumatic schematics (P&ID's)
- Knowledge of OSHA requirements and understanding of cGMP, GDP, and FDA requirements as they apply to processing
- Must be proficient in the use of Microsoft Office Applications, including Microsoft Project, Word, and Excel
- Understanding of engineering principles as they apply to facility and production equipment
- Hands-on ability to isolate problems and identify root cause of issues
- Comfortable working in production environment with multiple priorities
- Works effectively as a team member or as a team leader
- Effective oral and written communication skills
- Acute attention to detail
- Excellent time and project management skills
- Ability to handle multiple priorities in a fast-changing work environment
- Must be a creative thinker with good interpersonal relationship skills
- Strong project management and process improvement skills
- Strong cross-functional teamwork skills
- Excellent planning, project leadership, technical skills, and communication
- Ability to coordinate and resolve both interpersonal and technical problems
- Ability to work independently
- Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves
- Employee must be able to occasionally lift and/or move up to 15 pounds
Desired Qualifications
- 5 years' experience in pharmaceutical or a regulated similar industry
- 5 years maintenance experience
- Experience with regulatory interaction/auditing
- Experience with Validation and Investigation Reporting
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