OpEx Process Specialist I

The OpEX Process Specialist I provides technical/process support to maximize production efficiency. The position is visible on the manufacturing floor and has high interaction with the Production team. It’s expected that the OpEX Process Specialist I will drive process improvements and equipment effectiveness (equipment availability, operator efficiency and product yield). This position reports directly to the OpEx Manager and indirectly to Production Management.

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned)

• Develop a solid understanding of manufacturing processes / equipment – evolve into SME for assigned area. Equipment focus may cover syringe, vial or cartridge line / value stream, including lyophilizers, as well as packaging processes / equipment.
• As SME status achieved, serve as advisor to Building Leadership 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 (OEE).
• Participate and lead cross-functional continuous improvement initiatives (Kaizens) impacting performance and conversion loss
• Key member of the Total Productive Maintenance (TPM) team. Ability to manage multiple projects and work with cross-functional teams
• Review process trends to identify process improvements leading to VIPs, 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, operating, and troubleshooting procedures for Production, Maintenance, and Training personnel
• Ability to create, manage and approve Master Change Control and Work Orders
• Participate in and/or author investigation/analysis of complex issues and determine root cause(s) and implement innovative, cost effective corrective actions to prevent recurrence
• Act independently with minimal supervision
• Maintain Grade A/B aseptic gowning certification

Job Requirements (Education and Experience)

• Bachelor’s Degree preferred or 5+ years of pharmaceutical manufacturing experience
• 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,” utilizing problem solving skills to troubleshoot and improve complex equipment and systems
• Six Sigma Green Belt certification preferred; expectation will be to obtain at minimum a Green Belt certification.

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