Facility Engineer

Key Responsibilities

Equipment and System Ownership

• Serve as the technical lead for the specification, installation, qualification, operation, maintenance, and continuous improvement of assigned facility equipment and systems.
• Maintain a thorough understanding of equipment functionality, design, and operating requirements.
• Provide technical direction for the current and future design of assigned systems.
• Maintain system technology and identify opportunities to implement industry best practices.
• Own and maintain applicable standard operating procedures and work instructions.
• Develop technical training materials and troubleshooting guides.
• Review and maintain accurate piping and instrumentation diagrams and equipment specifications.
• Ensure that appropriate spare parts are identified and available within the inventory system.
• Perform and update technical risk assessments to identify critical equipment and optimize maintenance strategies.
• Provide technical expertise and support for Facilities Soft Services at site.

Reliability and Maintenance

• Improve equipment reliability, safety, and operational performance.
• Evaluate and optimize preventive maintenance activities based on equipment performance and risk.
• Implement and monitor predictive maintenance strategies to prevent unplanned equipment failures.
• Support Total Productive Maintenance practices to sustain equipment in like-new condition.
• Monitor performance indicators, including Overall Equipment Effectiveness, and implement improvements based on equipment data and trends.
• Coordinate technical activities during planned shutdowns.

Cross Functional Collaboration

• Collaborate with Environmental Health and Safety, Quality, Process Engineering, Manufacturing, Maintenance, Calibration, and other functional teams.
• Ensure that assigned equipment and systems can be operated and maintained safely.
• Support efforts to minimize quality deviations and improve equipment efficiency, yield, output, and capacity.
• Partner with technical experts to develop and update maintenance and calibration plans.
• Provide technical guidance and support during equipment-related investigations.

Asset Lifecycle and Capital Planning

• Analyze equipment data to identify technical improvements, capacity constraints, and replacement investments.
• Develop long-term strategies to address aging equipment, component obsolescence, and supply risks.
• Oversee equipment reconditioning and upgrades that improve safety, reliability, and operational performance.
• Develop end-of-life replacement plans that support uninterrupted supply to patients.
• Collaborate with local and global partners to develop asset-management strategies and supporting capital requests.

Compliance and Continuous Improvement

• Ensure that assigned equipment and processes comply with applicable government regulations, FDA requirements, cGMP standards, site procedures, and regulatory guidance.
• Serve as the equipment subject matter expert during internal audits and external regulatory inspections.
• Foster a culture of continuous improvement by promoting effective training, knowledge sharing, operational efficiency, and the elimination of non-value-added activities.
• Maintain a positive and equitable working environment aligned with CSL's values of Patient Focus, Innovation, Integrity, Collaboration, and Superior Performance.
• Comply with CSL Behring's safety program, including applicable health and safety requirements and OSHA standards.
• Perform other responsibilities assigned by senior management.

Qualifications

Education

• Bachelor's degree in Mechanical, Chemical, Manufacturing, or a related Engineering discipline. An equivalent degree may be considered based on relevant experience.
• Master's degree in a related Engineering discipline is a plus.

Experience

• Bachelor's degree with at least three years of relevant engineering experience; or Master's degree with at least two years of relevant engineering experience.
• Previous experience in the pharmaceutical or another highly regulated industry is preferred.
• Working knowledge of Good Manufacturing Practices.
• Knowledge of FDA requirements, cGMP standards, and applicable regulatory guidance.
• Experience supporting audits, technical investigations, and report writing.
• Proficiency with Microsoft Office applications.

Skills and Capabilities

• Strong technical problem-solving and analytical skills.
• Ability to evaluate equipment performance and translate data into sustainable improvements.
• Strong verbal communication, technical writing, and interpersonal skills.
• Ability to collaborate effectively across technical and operational functions.
• Ability to manage multiple priorities in a regulated manufacturing environment.
• Demonstrated commitment to safety, quality, reliability, and continuous improvement.