The Operations Specialist provides support to the day-to-day operations of the manufacturing facilities while also providing technical/process support as a Subject Matter Expert for the manufacturing filling lines. The position reports directly to the Manufacturing Manager II and functions as a building manager designee based upon business needs. The position requires interaction across multiple departments to ensure issue resolution in a timely manner and may also include interactions between clients and regulatory agencies. The position is also responsible for driving improvements in overall process and equipment effectiveness (equipment availability, operator efficiency and product yield), and leading complex investigations (and/or projects) related to manufacturing operations.

The Process Specialist 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). • Responsible for cartridge, syringe and vial lines / value stream, including component washer, depyrogenation tunnel, filling and stoppering machine, capper and tray loader. • 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• Key member of the filling line Perfect Equipment team • Ability to create, manage and approve Master Change Control, Equivalency Forms and Work Orders• Coach/mentor and train Maintenance Technicians and Production Operators• Maintain Grade A/B gowning certification

• Guide, support and lead through positive interactions with personnel during daily operations. • Supervise day-to-day production, scheduling, staffing, material management, compliance, and training and auditing activities.• Understand, follow, and direct manufacturing activities performed in aseptic/classified environments per current Good Manufacturing Practices guidelines. • Lead technical reviews, investigation, and process improvement projects (Kaizen). Provide manufacturing input into integration and validation of new equipment and processes.

• Delegate, coordinate, and schedule activities of assigned team members.• Recommend measures to improve performance and increase efficiency• Train and mentor other team members.• Troubleshoot process problems and respond to process alarms.• Participate on Continuous Improvement teams.• Assist in developing/reviewing batch records of new and existing projects.• Assist in establishing and orienting new projects for production• Review project plans and batch records prior to operations; monitor assigned team’s documentation in logbooks and batch records. • Organize and coordinate general cleaning and sanitizations throughout all filling suites.• Identify potential causes and verify/eliminate each one to determine the true root cause behavior