Sr Utilities Engineer

Main Responsibilities & Accountabilities

• Technical lead accountable for the operational improvement of the utility systems based upon industry trends and emerging technologies.
• Responsible for compliance and operational improvement of equipment systems.
• Provide engineering support to address operational / compliance issues and to ensure equipment is maintained at a level required to provide high reliability maximizing useful life.
• Implement measures to improve equipment that support utility operations.
• Provide technical expertise and industry best practices.
• Lead engineering efforts to resolve equipment and operational problems and ensure problem solving techniques are appropriately utilized.
• Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments and participates in validation activities including review of IQ/OQ protocols, executions and summary reports.
• Provide technical support to operations, maintenance, manufacturing, automation, quality assurance, validation, reliability engineering and project engineering.
• Support the planning and execution of activities by working in cross-functional teams assisting in driving projects to completion to meet timeline and budget objectives.
• Manage system documentation including creation, review, updates, and approval of technical specifications, operating procedures, and system drawings.
• Accountable for the Utility Reliability Program: Execute the maintenance strategy for new and modified equipment; Management of CMMS data integrity and execution of Reliability Centered Maintenance Improvements; Develop preventative maintenance procedures for utility systems in collaboration with the Reliability Engineering department ensuring maintenance programs are implemented; Continuous Improvement of maintenance PM’s, BOM’s and Spare Parts.
• Review and lead utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning.
• Oversees reconditioning of the equipment to restore to like-new condition.
• Performs upgrades to improve safety, operational performance, and extend operational life.
• Collaborates with local and global partners to develop asset management plan that includes capital requests.
• Manage and monitor KPI’s: Ensure compliance with site and global indicators; Measure and ensure compliant performance in Safety, Quality and Reliability; Demonstrate success of preventative maintenance improvements through performance reports, dashboards and metrics; Utilize control systems to monitor, trend and verify equipment performance and downtime.
• Ensure cGMP compliance of all utility systems to meet regulatory compliance: Equipment is maintained at a level required to provide high reliability maximizing useful life; Review environmental monitoring and laboratory sample release test results; Manage deviations, investigations (CAPA’s and OOT’s) with on-time closure; Safely resolve process problems, improve efficiency, reduce waste, and maximize uptime production; Execute root cause analysis during investigations; Lead investigations as the subject matter expert providing technical expertise for all phases associated with the utility systems.
• Responsible for the development and maintenance of the utility drawings, flow diagrams and Standard Operational documents.
• Perform utility inspections for quality assurance on a periodic basis and initiate any procedures necessary to resolve problems.
• Responsible for utility inspections (GEMBA’s/audits) for quality assurance on a periodic basis.
• Responsible to ensure training, deviations and investigations related to utility systems have on-time closure and KPI performance metrics are met.
• Responsible for change control activities, the implementation of CAPA items, quality investigations and determine/implement long lasting corrective actions and preventative measures.
• Support all scheduled capital projects related to utility system shutdowns, tie-ins and system startup.
• Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to biopharmaceutical industry engineering best practices and technologies, as well as technical understanding/problem solving capability.
• Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
• Completes any other duties/responsibilities assigned by senior management.

Additional Responsibilities and Accountabilities (Clean System)

• Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the Clean Utility systems.
• Play an essential leadership role in support of the operation on project support activities.
• Responsible for the Clean Utility generation and distribution systems across the site. These systems include clean steam, purified water, clean air, WFI, clean gases and other ancillary equipment.
• Responsible for the quality requirements and the applicable regulatory standards, such as USP, EU and JP.
• Technical lead in engineering, with a focus on pharmaceutical utility systems, industry best practices, and emerging technologies related to utility systems requirements.