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Job Description

About the role:

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

How you will contribute:

Primary responsibilities of this role include:

• Troubleshooting and providing timely resolution to technical issues in support of ramp-up and steady-state operations of a highly automated pharmaceutical manufacturing facility.

Scope of support will include:

• 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.

Continuously improve manufacturing operations by:

• 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.

• Actively supporting information sharing and learning between team members by:

• 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.

• 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.

What you bring to Takeda:

• Bachelor’s degree in Engineering, discipline required. Some related experience preferred.

• Related work experience within a technical or GMP environment is preferred.

Key Skills, Abilities, and Competencies:

• Knowledge of 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.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may