Production Engineer II - Takeda Pharmaceuticals : Job Details

The Production Engineer II is responsible for on-shift operational support of the Fractionation department in Covington, GA. The Production Engineer II focuses on rapidly resolving manufacturing problems and enabling manufacturing to meet production goals. As a member of the operations team, the Production Engineer II provides on shift technical knowledge and leadership. The Production Engineer II will also be involved in supporting improvements within manufacturing.

• Troubleshooting and providing timely resolution to technical issues in support of ramp-up and steady-state operations of a highly automated pharmaceutical manufacturing facility.
• Plasma Fractionation processes
• Process equipment (vessels, centrifuges, filter presses, robotics, COP washers, CIP skids)
• Distributed Control System (DeltaV) and Process Logic Controllers
• Manufacturing Execution System (Siemens Simatic IT)
• Automation hardware
• In Process Testing lab (pH, conductivity, titration)
• Safety and quality investigations
• Reducing manufacturing events, user interventions, and batch record alerts.
• Identifying and developing opportunities to reduce cycle time, error proof operations, and eliminate waste.
• Performing operational assessments to ensure proper processes, procedures, tools, and training are in place.
• Investigating and resolving issues assigned from the departmental issues log.
• Supporting projects and Continuous Improvement efforts.
• Assisting Manufacturing and Quality departments in CAPA investigations.
• Interfacing with other departments to resolve issues related to equipment, processes, and compliance, including maintenance, metrology, and validation.
• Completing relevant paperwork following GDP/GMP guidelines.
• Leading Knowledge Transfer training with manufacturing staff.
• Coaching manufacturing staff while partnering with them to resolve technical issues.
• Developing troubleshooting guides for common problems.
• Sharing process knowledge with colleagues across-shift.

• Bachelors degree in Engineering discipline required. 2+ years of related experience.
• Experience with basic engineering principles in various engineering disciplines.
• Ability to solve routine engineering problems with minimal assistance.
• Ability to discuss normally encountered technical issues, both verbally and in written form.
• Ability to work as a collaborative team member.
• Self-driven individual that requires minimal supervision.
• Initial training in concepts of Lean Manufacturing and Six Sigma quality techniques is preferred.
• Ability to work 12-hour shifts, including nights, weekends, and holidays in support of a 24 x 7 manufacturing operation.
• Ability to work in a clean room environment.
• Ability to wear personal protective equipment (such as hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas.
• Ability to travel on an infrequent basis (