Manufacturing Process Specialist
7 days ago
The Production Engineer I is responsible for providing on-shift operational support to the manufacturing process and contributing to ramp-up activities. This role reports to an Engineering Manager at our Social Circle, GA location.
This position will align with either a night shift or day/night shift.
Key Responsibilities- Troubleshoot and resolve technical issues to support ramp-up and steady-state operations of an automated pharmaceutical manufacturing facility.
- Support the IG process, process equipment, Distributed Control System (DeltaV), Process Logic Controllers, Manufacturing Execution System (Siemens Simatic IT), automation hardware, In Process Testing lab, and Safety and quality investigations.
- Reduce manufacturing events, user interventions, and batch record alerts.
- Develop opportunities to reduce cycle time, error-proof operations, and eliminate waste.
- Perform operational assessments to ensure processes, procedures, tools, and training are in place.
- Investigate and resolve issues assigned from the departmental issues log.
- Support Process Unit Team projects and Continuous Improvement efforts.
- Lead Knowledge Transfer training with manufacturing staff.
- Coach manufacturing staff while partnering with them to resolve technical issues.
- Develop troubleshooting guides for common problems.
- Share process knowledge with colleagues across-shift.
- B.S. degree in an engineering or scientific discipline (Chemical Engineering preferred).
- 0 to 4+ years of related work experience, preferably within a GMP environment.
- Experience with basic engineering principles in multiple engineering disciplines.
- Experience solving routine engineering problems with assistance.
- Familiarity with addressing normally encountered technical and project management issues.
- Familiarity with concepts of Lean Manufacturing and Six Sigma quality techniques is preferred.
- Experience leading small teams and working as a collaborative team member.
- In general, you will have a combination of sedentary work and walking around observing conditions in the facility.
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.
- You may wear personal protective equipment (PPE) and other clean room garments daily.
- You may need to remove all make-up, jewelry, contact lenses, nail polish, and artificial fingernails while in the manufacturing environment.
- You will work in a cold, wet environment.
- You will work up to 12 hour shifts, including nights, weekends, and holidays in support of a 24 x 7 manufacturing operation.
- You will work overtime as required.
- You may work in a confined area.
- You may work in Clean Room and cool/hot storage conditions.
- You may travel up to 5%.
- You may work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.
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