Production Engineer I - IG Albumin
TakedaAbout the role
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Job Description
About the role:
The Production Engineer IG is responsible for on-shift operational support of the IG Manufacturing Process and to support ramp up activities. You will report to an Engineering Manager at our Social Circle, GA location.
This role will align with either a night shift, or day/night shift.
How you will contribute:
- Troubleshoot and provide resolution to technical issues to support ramp-up and steady-state operations of an automated pharmaceutical manufacturing facility. Scope of support will include:
- IG process anomalies
- Process equipment (Vessels, SIP Skids, Vial Filling equipment, Isolator, Chromatography, COP washers, CIP skids, )
- Distributed Control System (DeltaV) and Process Logic Controllers
- Manufacturing Execution System (Siemens Simatic IT)
- Automation hardware
- In Process Testing lab
- 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
- Performing 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
What You Bring to Takeda:
- 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
- Familiar addressing normally encountered technical and project management issues
- Familiar with concepts of Lean Manufacturing and Six Sigma quality techniques is preferred
- Experience leading small teams and work as a collaborative team member
- In general, you will have a combination of sedentary work and walking around observing conditions in the facility.
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. You may:
- May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
- Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Will work up to 12 hour shift, including nights, weekends, and holidays in support of a 24 x 7 manufacturing operation
- Will work overtime as required. (only for non-exempt positions)
- May work in a confined area.
- Some Clean Room and cool/hot storage conditions.
- 5% Travel.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More About Us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a pa
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