Sr. Principal Engineer- Utilities

The Utilities Engineer is responsible for establishing and maintaining reliable operation and qualified state of clean utility systems and supporting grey systems that support Biotech manufacturing. The Utilities Engineer will ensure that processes are in-control, compliant, and capable of meeting manufacturing needs, while also driving continuous improvement.

Key Responsibilities

• Ensure a safe working environment by following safety rules and helping improve the safety culture.
• Provide clean system engineering expertise as an active member of area team.
• Clean system unit operations and equipment are maintained and are in a qualified and reliable state.
• Establish and/or monitor the critical parameters for all clean systems to ensure that these are in control.
• Lead Troubleshooting efforts to resolve difficult unit operations, equipment and operational issues.
• Evaluate all activities for impact on qualified state of equipment and utilize appropriate tools as necessary.
• Supporting the grey utility Facility Start-Up: Provide engineering support to the Global Facility Delivery Team with a strong focus on right first time and on-schedule facility start-up. This includes design reviews, process safety assessments, user requirements, C&Q support, unit operation shakedown and start-up, facility operational readiness.
• Define and own relevant aspects of the overall integrated operational readiness plan (e.g. SOP development, maintenance strategy, automation optimization, pre-startup safety reviews, alarm requirements, performance qualification requirements/protocol development, etc.)
• Own the qualified state of equipment for respective area of responsibility
• Develop and implement unit operation and equipment control strategy to sustain and optimize utilities systems in support of manufacturing operations
• Support initial operations training requirements as the equipment and area SME
• Safety: Take responsibility for the safe design and safe operation of the equipment within the area. Actively participate in safety-related activities (audits, hazard reviews, pre-start up safety reviews) to drive ongoing safety improvement.
• Bio-process Technical Support: Be the point of contact and be the technical expert for equipment and processes in area of responsibility. This includes clear understanding of unit operations and associated equipment operations.
• Monitor the utility systems and optimize the unit operations and equipment performance.
• Lead troubleshooting efforts relating to unit operations, equipment and operational issues.
• Utilize formal problem-solving techniques, including Root Cause Analysis, to resolve unit operations and equipment issues.
• Respond to unit operations issues and equipment failures, document appropriately and ensure resolution of events through appropriate actions.
• Communicate effectively with others, especially team members, operations and crafts personnel.
• Maintain Qualified and Reliable State: Evaluate all activities for impact on qualified state of unit operations/equipment and utilize appropriate business processes as necessary (change control etc).
• Responsible for system/component classification and maintenance strategy for equipment.
• Implement corrections, corrective actions, and countermeasures arising from investigations.
• Participate in Periodic Reviews for systems and equipment.
• Lead IQ/OQ/PQ activities (including commissioning activities of new unit operations/equipment)
• Asset Management: Develop scope for capital projects targeted at both short- and longer-term needs.
• Act as user representative for local projects.
• Understand equipment reliability issues with the objective of improvement.
• Aid the coaching of operators and maintenance technicians in the effective use of equipment
• Improve Business: Identify and drive improvement opportunities (procedural changes, upgrades, projects etc) associated with unit operations/equipment within the area.