Backed by 500 Global.
About the role
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.
What they're looking for
- 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
More about this role
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.
- 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...
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