Senior Controlled Temperature Unit Engineer Job in Point, Pennsylvania US
Senior Controlled Temperature Unit Engineer
As a member of the Engineering Maintenance/Utility Department, the primary role of the Controlled Temperature Unit (CTU) Senior Engineer is to serve as the Subject Matter Expert for over 300 CTUs including 2-8C, -20C through -70C walk-in and reach-in freezers. The Sr. CTU Engineer will be responsible to ensure overall system compliance, provide/improve asset reliability, capacity upgrades and life cycle development in a large Pharmaceutical/Vaccine manufacturing site. This includes optimization management of all CTUs from a mechanical, automation and process control perspective. Provides technical support to ensure equipment is operated and maintained in compliance with all quality, safety, and environmental requirements Interacts and directs hourly, salaried and contract employees in troubleshooting systems and equipment while ensuring effective labor and employee relations Designs, develops, monitors, and refines the preventive/predictive maintenance processes Evaluates, develops, and improves business processes and develops technical rationale for system improvements, using analytical and data-driven decision-making techniques Serves as technical liaison for capital projects to ensure compliance, reliability, maintainability and operability of installed equipment, including supporting, qualification and start-up activities Develops and directs Installation, Qualification, Change Control, SOP, and Preventive Maintenance documentation, and provides reports, data and information to on-going operations as required Executes CTU performance monitoring, maintains record utility drawings participates in auditing and training activities Provides technical support for quality deviation investigations, and performs root cause failure analysis on equipment failures and develops strategies to prevent recurrence, supports regulatory inspections including interacting with regulatory investigators