Sterilization Process Engineer

Description:

Day to Day Responsibilities:

• Actively collaborate with other site engineers, operations personnel, and suppliers to maintain and improve operations
• Work with operations to gather support needed, information, and provide updates on process status
• Quickly respond to production and process upsets, troubleshoot production issues, diagnose problems, and implement corrective action (machine fix, process change, etc.) to reestablish operations
• Work with operations to further develop SPC/SQC for process discipline and control (PD/PC)
• Provides technical leadership in assigned processes and escalate issues appropriately
• Act to continuously improve and expand the core process capabilities
• Use of engineering first principles like MEE to drive mechanistic understanding and root cause identifications
• Responsible for providing technical expertise and strategic direction for sterilization
• Supporting and executing activities related to development, validation, routine sterilization and requalification activities
• Lead and work collaboratively across project teams as assigned, which may include commercial product support, continuous improvement activities, innovation projects, or other activities related to sterilization
• Reviewing and analyzing process data for trends and improvement areas
• Monitor internal asset performance with focus to 98% uptime
• Documents changes via the change control process
• Train maintenance and operations personnel on processes and machinery to transfer operations knowledge and ensure operational efficiency and product quality
• Must respond to off-hours calls (rotating coverage schedule) to resolve process upsets or systems downtime events; occasionally must flex working schedule as required to meet business needs
• Provide indirect leadership to assigned technical and hourly associates to achieve departmental quality, quantity, service, cost, and safety goals