Process Specialist-1400051T

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Description Summary: The Process Specialist I provides technical/process support as a Subject Matter Expert for the manufacturing filling line operations with the goal of maximizing production efficiency. The position is visible on the manufacturing floor. It has high interaction with the production team to resolve issues during manufacturing. Drives improvements in overall process and equipment effectiveness (equipment availability, operator efficiency and product yield). Essential Duties and Responsibilities: · Develop a solid understanding of filling line manufacturing processes/equipment – evolve into SME for assigned area. Primary responsibility for a syringe line (filling process/equipment). · As SME status achieved, serve as advisor to BLT relative to assigned equipment and processes. · Develop a solid understanding Lean/Six Sigma tools: SPC, CPk, Statistics, Pareto, Fishbone, 5-Why’s, etc. Utilize these tools to drive improvements in overall equipment effectiveness. · Participate in cross functional continuous improvement initiatives that directly impact operations performance · Participate in investigation/analysis of complex issues and determine root cause(s) and implement innovative, cost effective corrective actions to prevent recurrence · Support team deliverables for equipment related processes · Review process trends to identify areas of improvements, including: equipment downtime (PM’s, spare parts, equipment/tooling design), operator efficiency (set-up, tear-down, overall batch run speed) and product yield issues · Responsible for standardization/training of set-up and basic troubleshooting procedures for Production Leadership and SME identified Operators · Member of the filling line Perfect Equipment team · Ability to create, manage and approve Equivalency Forms and Work Orders · Coach/mentor and train Maintenance Technicians and Production Operators · Act independently with minimal supervision · Maintain Grade A/B gowning certification Qualifications Job Requirements: · Associate’s Degree or equivalent experience in manufacturing pharmaceutical operations · Understanding of Good Manufacturing Practices · Computer proficiency in Word, Excel, and Outlook and the ability to use enterprise software, such as BPLM, Maximo, Trackwise, etc. · Must have the ability to work effectively in a ”hands on environment” capable of troubleshooting complex equipment and systems Physical / Safety Requirements: · Must be able to lift up to 50 lbs · Duties may require overtime work, including nights and weekends · Extended periods of standing and/or walking · Extended periods in Grade A, B, C, D production environments · Use of hands and fingers to manipulate equipment is required
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