What Youll Do
Coordinates with Senior Utility Engineers within assigned discipline to ensure project deliverables (e.g. specification review Factory Acceptance Tests (FATs) and visits equipment installation and issue resolution) are performed to the company standards
Develops Project Change Controls (PCCs) to document specific changes to the design of systems within assigned discipline
Prepares deviations and change control resolutions and closures
Performs reviews of submittals installation and testing of equipment within assigned discipline across all buildings on site
Performs field walkdowns with Utility Engineering and Construction personnel to ensure systems are installed per approved standards and drawings
Provides engineering technical support for all plant utilities and systems (e.g. plant steam boilers cooling systems compressed air etc.)
Reviews and approves Preventative Maintenance templates for equipment within assigned discipline
Collaborates with Utility Operators and Maintenance Technicians to resolve operational issues
Develops or provides supports in the development of User Requirement Specs (URSs) Standard Operating Procedures (SOPs) and equipment maintenance and troubleshooting procedures
Provides support for the implementation of maintenance strategies to maximize equipment reliability in conjunction with Senior Engineers
Maintains Good Manufacturing Practices (GMP) compliance aspects of validated systems
Participates in audits with customer representatives and regulatory agencies as needed
Performs simple to moderate troubleshooting for equipment challenges and supports Senior Engineers with complex troubleshooting
Cross-trains within multiple disciplines to assist team with achieving deliverables
Collaborates with other departments (e.g. Utility Operations Maintenance Facilities Environmental Health and Safety)
Other duties as assigned
Knowledge & Skills
Effective communication both written and verbal
Knowledge of cGMP and European Medicines Evaluation Agency (EMEA) or Food & Drug Administration (FDA) regulations
Proficient in Microsoft Office (e.g. Word Excel PowerPoint SharePoint)
Ability to analyze and troubleshoot simple to moderate system and component related issues
Ability to effectively present information to others
Willingness to provide feedback to others including leaders
Required Skills
Bachelors Degree in Engineering with 5 years of experience with process utility related components and systems
Experience working in a GMP or other highly regulated environment
Preferred Skills
Experience establishing processes and procedures for operation troubleshooting and monitoring process utility systems
Working Conditions & Physical Requirements:
Will work in environment which may necessitate respiratory protection No X Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color. No X Yes
Ability to ascend or descend ladders scaffolding ramps etc. No X Yes
Ability to stand for prolonged periods of time. No X Yes 60 minutes
Ability to sit for prolonged periods of time. No X Yes 60 minutes
Ability to conduct activities using repetitive motions that include writs hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes 10 lbs. X 50 lbs.
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions. No X Yes