United States of America
The Utilities Engineer is responsible for oversight of design, operational and troubleshooting support for the clean utility distribution systems that include WFI, RO, Purified Water, Clean Steam and Process Gases with knowledge of associated plant utilities.
The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, automation, quality assurance, validation and project engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support.
• Under general supervision supports utilities operations (plant and clean utility, ethanol, HVAC)
• Ensures operations comply with cGMP and company standards for quality, health, safety and the environment
• Investigates plant failures and operating incidents, determines cause and recommends and implements solutions
• Analyzes maintenance history, waste and energy usage and process models and recommends improvement plans
• Provides technical support, project briefs, system requirements and preliminary budgets for facility modifications, upgrades and capital projects
• Maintains quality standards, risk assessments and Company standard operating procedures (SOPs)
Main Responsibilities and Accountabilities:
- Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the clean utility systems.
- Focus on providing support for existing and new utility systems. Review and make recommendations to management for clean utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning.
- Play an essential leadership role in the operation and troubleshooting of the clean utility systems.
- Serve as the clean utility subject matter expert. Provides technical expertise for all phases associated with utility/facility systems.
- Perform regular field walk-through tours and inspections and initiate any procedures necessary to resolve problems.
- Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives.
- Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures.
- Collect, analyze and report data for use by the Utilities and Operations department to ensure reliable operation.
- Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits.
- Provide guidance for support personnel and helps drive development of PM programs.
- Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the clean utilities system.
- Participate in validation activities including review of IQ/OQ protocols, executions and summary reports.
- Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating P&IDs.
- Manage small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions.
- Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT’s/SAT’s, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications.
- Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup.
- Assist with developing predictive and preventative maintenance program for utility systems.
- Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability.
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