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Job description
Position Overview
The Clean Utilities Engineer 3 provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Clean Utilities, including reverse osmosis/electrodeionization (RO/EDI) skids, water for injection (WFI), purified water (WPU), Clean gasses and applicable waste systems. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability. Additional responsibilities includes supporting deviation investigations and documentation for associated system deficiencies.
Job Description
What You’ll 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 and 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 utilize software programs related to job responsibilities
Ability to analyze and troubleshoot system and component related issues
Ability to effectively present information to others
Basic Requirements
Bachelor’s 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 Requirements
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 YesMay 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. No X Yes Ability to discern audible cues. No X YesAbility 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 YesAbility to stand for prolonged periods of time. No X Yes 30 minutes Ability to sit for prolonged periods of time. No X Yes 120 minutesAbility to conduct activities using repetitive motions that include writs, hands and/or fingers. X No YesAbility to operate machinery and/or power tools. X No YesAbility to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 33 lbs.Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes
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Worksite address
holly springs, NC, 27540, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.