Nature and Scope

The Sr. Utility Engineer is responsible for operating, maintaining, and improving process/plant utilities and systems that support all Ohio American Regent facilities. Scope includes industrial systems such as plumbing, plant steam, power distribution, cooling system, compressed air, gases, heating hot water, chilled water, and all clean utilities (steam, WFI, Purified Water, RO/EDI). The incumbent has responsibility for indirectly supervising and directing internal resources as well as contract service providers. The individual will be responsible for providing Subject Matter Expertise (SME) for all utilities systems. This position will be required to develop, follow, and maintain procedures to assure utility systems and associated processes adhere to cGMP's, company, local and state requirements, including health and safety requirements. The Sr. Utility Engineer must be able to manage multiple tasks simultaneously, manage projects on time and under budget, drive project procurement, implementation, and project closure in a FDA regulated environment. This is a hands-on role and will focus on supporting equipment and processes required to support an aseptic manufacturing and packing operation. This role requires the ability to chair meetings, present topics to the leadership team, provide constant, thorough, and professional communication throughout all levels of the organization.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Lead Capital Projects

• Develop scope, budget, URS and manage all phases of projects to completion.
• Coordinate process utility support activities such as equipment reconfiguration, changeover, replacement planning, etc.
• Support factory acceptance of equipment. Review specifications, drawings and submittals and provide input.
• Develop and maintain up to date drawings of new and/or existing equipment, systems, and processes.

Coordinate handover from Engineering to Maintenance and Operations

• Work with engineering team to review specifications and provide input
• Accept turnover packages and establish maintenance programs.
• Support qualification activities including protocol generation/review/execution.
• Position has responsibilities at multiple locations in central Ohio.

Optimize Utilities

• Perform capacity analysis of each system and make recommendations for improvements.
• Review/modify existing and develop new operating and preventive maintenance procedures for the utilities and systems.
• Develop and review metrics on utility systems.
• Develop schedules for preventative maintenance and support shutdown activities and scheduling of PM/repair work.
• Evaluate breakdown statistics and adjust maintenance plans appropriately.
• Increase utility equipment availability through reduction of breakdowns.
• Asist with the engineering design and troubleshooting the reliable, safe, and efficient operations.
• Support Quality Assurance investigations of utility issues.
• Ability to acquire data, organize, analyze, and reach accurate conclusions.
• Working knowledge of statistical methods used to develop metrics.
• Work with Engineering Team to review specifications and provide input.
• Facilitate completion of change control documentation.
• Develop training modules; provide coaching/feedback to develop/enhance technical personnel capabilities.
• Provide technical troubleshooting support to mechanics responding to breakdowns
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

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, and the drive to complete projects thoroughly is required, as is the 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, as well as strong cross-functional teamwork skills.
• Job assignments are complex in nature and require excellent planning, project leadership, technical skills, and communication to be successful in meeting project objectives. The Engineer must be able to coordinate and resolve both interpersonal and technical problems and work independently.
• Role Models "can-do" attitude. Reinforces positive approach in daily group activities. Readily adapts to changing job duties. Establishes culture that emphasizes responsiveness.
• Comfortable working in production environment with multiple priorities. Works effectively as a team member or as a team leader.
• Ability to clearly and concisely express thoughts in written procedures, protocols, and reports. Ability to write procedures that clearly define required tasks. Ability to proofread other's work for accuracy. Ability to generate presentations/reports to explain and/or analyze areas of responsibility.

Preferred 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.

Physical Environment and Requirements

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.
• Employee must be able to occasionally lift and/or move up to 15 pounds.