Utilities Engineer (FY07-211)

Job Description:

 

A technical position responsible for operating and maintaining plant utility systems that support manufacturing. Position has responsibility for supervising/directing internal resources as well as contract service providers.

Manage Process PM/Repair Program: Technically review maintenance procedures. Establish and maintain metrics on PM and repair programs. Coordinate shutdown activities and scheduling of PM/repair work. Review Maintenance Paperwork. Evaluate breakdown statistics and adjust maintenance plans to suit. Increase utility equipment availability through reduction of breakdowns. Monitor utility equipment operation and implement corrective actions for out of specification operation and alarms. Optimize spare parts stocking program. Support Quality Assurance investigations of utility issues. Coordinate breakdown repair activities and serve as customer point of contact. Develop, conduct and document test methods for utility systems troubleshooting. Facilitate completion of change control documentation. Support Facilities/Utilities Department: Develop training modules; provide coaching/feedback to develop/enhance technical personnel capabilities. Ensure effective and up to date training. Provide technical troubleshooting support to mechanics responding to breakdowns. Manage Utility Projects Identify utility process improvement projects, develop scope and estimates, and manage projects to completion. Coordinate process utility support activities such as equipment reconfiguration, changeover, replacement planning, etc. Coordinate Handover of Utility Equipment from Engineering: Work with engineering team to review specifications and provide input. Accept turnover packages and establish maintenance programs.

 

Job Requirements:

 

BS in Engineering preferred. Three to Seven years of maintenance experience. One to Three years experience in pharmaceutical or other regulated industry. Technical knowledge: Understanding of engineering principles as they apply to facility and production equipment. Understanding of maintenance strategies and techniques. Understanding of Continuous Improvement Principles. Utility Maintenance and Operation: 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. Ability to size and specify Utility equipment. Experience with coordinating large scale shutdown/turnarounds. Proven record of cost containment. Trouble Shooting: Hands-on ability to isolate problems and identify root cause of issues. Proven ability to teach others how to fix things. Ability to analyze data to identify trends and establish corrective actions. Regulatory: Knowledge of OSHA requirements. Understanding of cGMP, GDP, and FDA requirements as they apply to maintenance. Experience with regulatory interaction/auditing. Pharmaceutical Operations: Sanitary piping principles including pipe specification, valve configuration, pump setup, etc. Experience with Validation and Investigation Reporting. Writing Skills: Ability to clearly and concisely express thoughts in written procedures, protocols, and reports. Ability to write maintenance procedures that clearly define required tasks. Ability to proofread other?s work for accuracy. Computer Systems: Working knowledge of Process Control and Instrumentation Systems. Working knowledge of typical office automation software suite. Ability to generate presentations/reports to explain and/or analyze areas of responsibility. Thorough knowledge of statistical methods used to develop maintenance metrics. Thorough mechanical and chemical engineering knowledge as it applies to general production equipment, and drug product facility systems and equipment. Thorough knowledge of electricity, electrical controls, electronic and instrumentation systems. Knowledge of computer systems operation and software. Knowledge of CGMP, OSHA, EPA and FDA facility requirements and regulations. Organizational Skills: Comfortable working in production environment with multiple priorities. Works effectively as a team member or as a team leader. Able to juggle multiple tasks while supervising group. Management: Able to develop vision for group consistent with corporate goals, gain acceptance and implement. Comfortable establishing culture of performance. Able to effectively delegate while retaining oversight of important tasks. Positive Attitude. Role Models ?can-do? attitude. Reinforces positive approach in daily group activities. Readily adapts to changing job duties. Troubleshooting: Superior ability to acquire data, organize, analyze, and reach accurate conclusions. Sense of Urgency. Establishes culture that emphasizes responsiveness. Works to ensure that customer timelines are understood and met.

 

Why Alkermes? 

 

Alkermes is a world leader in the development of products based on sophisticated drug delivery technologies.  We partner with many of the world?s finest pharmaceutical companies and leverage our own proprietary technologies that make a difference in people?s quality of life.  Our business is demanding, yet we strive to make Alkermes a company where people can grow, excel and have a rewarding personal and professional experience.  We are a mature company with established products and product technologies, yet we are small enough that every employee makes a difference ? and contributions are clearly recognized.  In addition to a competitive salary, Alkermes offers a comprehensive benefits plan including Medical/Dental Insurance, 401(k) plan with immediate vesting, stock options, and a generous vacation and holiday schedule.

 

Headquartered in Cambridge, MA, our Wilmington, Ohio manufacturing facility is expanding operations and product lines. For more information please visit www.alkermes.com.