Sr. Utility Engineer

American Regent, Inc.•New Albany, OH

6d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
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.
Assist 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.