System Owner Role Overview
This position is part of the Site F&E (Facilities & Engineering) group, and the successful candidate will be responsible for owning certain Equipment Systems on site within the group.
The System Owner reports to the Sr. Manager – Utilities Engineering and has knowledge and proficiency in various areas, including GMP and nGMP systems, statistical analysis tools, continuous improvement methodologies, problem-solving, and applied engineering relating to systems and equipment.
Key Responsibilities:
* Lead Root Cause Analysis (RCA), investigations, deviations for operational issues related to owned Systems.
* Liaise with Manufacturing, QA, and Labs on performance issues and with EHS on Safety and Environmental concerns.
* Act as site contact (Subject Matter Expert) for external and regulatory audits.
* Roll out training on Systems for which the candidate is designated SME/System Owner.
* Drive Continuous Improvement in performance elements of owned Systems.
* Engage actively in Work Centre Teams as SME for Equipment and Systems owned.
System Ownership Responsibilities:
* Measure and maximize uptime of assigned Systems.
* Monitor day-to-day performance of Systems.
* Analyze data trends of all performance aspects of Systems and equipment to identify and proactively manage performance trends.
* Troubleshoot performance trends.
* Conduct risk assessments and mitigation projects relating to system performance.
* Evaluate and implement preventative maintenance schedules for Systems.
* Implement predictive maintenance methodologies and best practice maintenance governance.
* Maintain critical spare parts lists for Systems and ensure appropriate spares are held.
* Define and scope improvement activities related to Systems.
* Own interactions and understand interface of Systems with BMS or PCS Systems on site.
* Participate in design reviews for equipment purchases/changesto Systems.
* Manage Quality System Triage sessions, investigations, deviations, and CAPAs associated with Systems.
* Develop and execute FAT, SAT, and IOQ protocols.
* Represent F&E on site-based teams implementing new technology, products, or business processes.
* Review and approve changes to operating procedures and change control process for Systems.
* Complete CMMS administrative WOs associated with Systems.
Basic Qualifications:
* Bachelor's degree in Engineering (Mechanical, Electrical, Chemical).
* Experience in Pharmaceutical or BioTechnology industries, in a direct or supportive Equipment Owner role, preferred.