BioSpace
About the role
The Production Engineer I – Albumin & Fractionation provides on-shift operational support for the Albumin and Fractionation departments at our Covington, GA manufacturing site. This role is critical to ensuring smooth and efficient production by rapidly resolving technical issues and enabling the team to meet manufacturing goals.
Responsibilities
Troubleshoot and resolve manufacturing challenges during ramp-up and steady-state operations across two highly automated pharmaceutical manufacturing facilities.
Provide technical expertise and leadership during shift operations, supporting the team to meet manufacturing goals.
Drive continuous improvement by reducing manufacturing events, user interventions, and batch record alerts; identify opportunities to reduce cycle time, error-proof operations, and eliminate waste.
Conduct operational assessments to ensure processes, procedures, tools, and training are optimized.
Investigate and resolve issues from the departmental issues log.
Support Process Unit Team projects and continuous improvement initiatives.
Lead knowledge transfer sessions with manufacturing staff, coach team members, and develop troubleshooting guides for recurring problems.
Share process knowledge across shifts to promote consistency and best practices.
Scope of Support
Processes: IG Purification, Filling and Packaging, Fractionation, and Albumin Purification
Equipment: Vessels, Filtration Systems, Chromatography Columns, UF/DF Units, COP Washers, CIP Skids, Filter Presses, Automatic Bottle Openers, Centrifuges, Isolators, and Packaging Lines
Systems: Distributed Control System (DeltaV), Process Logic Controllers, Manufacturing Execution System (Siemens Simatic IT), and Automation Hardware
Laboratory Support: In-Process Testing (pH, Conductivity, Titration)
Compliance: Safety and Quality Investigations
Qualifications
Bachelor’s degree in an engineering discipline or equivalent experience in a technical or GMP-regulated environment.
Solid understanding of basic engineering principles across multiple disciplines.
Ability to solve routine engineering problems independently and communicate technical issues clearly—both verbally and in writing.
Strong collaboration skills and a team-oriented mindset.
Self-motivated and capable of working with minimal supervision.
Exposure to Lean Manufacturing and Six Sigma methodologies is a plus.
Willingness and ability to work 12-hour shifts, including nights, weekends, and holidays, in support of a 24/7 manufacturing operation.
Comfortable working in a clean room environment and adhering to safety protocols.
Ability to wear personal protective equipment (e.g., hard hats, safety shoes, safety glasses, ear plugs) as required.
Willingness to travel occasionally (less than 5%).
Locations USA - GA - Social Circle - Hwy 278
Salary U.S. Base Salary Range: $56,000.00 - $88,000.00
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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Responsibilities
Troubleshoot and resolve manufacturing challenges during ramp-up and steady-state operations across two highly automated pharmaceutical manufacturing facilities.
Provide technical expertise and leadership during shift operations, supporting the team to meet manufacturing goals.
Drive continuous improvement by reducing manufacturing events, user interventions, and batch record alerts; identify opportunities to reduce cycle time, error-proof operations, and eliminate waste.
Conduct operational assessments to ensure processes, procedures, tools, and training are optimized.
Investigate and resolve issues from the departmental issues log.
Support Process Unit Team projects and continuous improvement initiatives.
Lead knowledge transfer sessions with manufacturing staff, coach team members, and develop troubleshooting guides for recurring problems.
Share process knowledge across shifts to promote consistency and best practices.
Scope of Support
Processes: IG Purification, Filling and Packaging, Fractionation, and Albumin Purification
Equipment: Vessels, Filtration Systems, Chromatography Columns, UF/DF Units, COP Washers, CIP Skids, Filter Presses, Automatic Bottle Openers, Centrifuges, Isolators, and Packaging Lines
Systems: Distributed Control System (DeltaV), Process Logic Controllers, Manufacturing Execution System (Siemens Simatic IT), and Automation Hardware
Laboratory Support: In-Process Testing (pH, Conductivity, Titration)
Compliance: Safety and Quality Investigations
Qualifications
Bachelor’s degree in an engineering discipline or equivalent experience in a technical or GMP-regulated environment.
Solid understanding of basic engineering principles across multiple disciplines.
Ability to solve routine engineering problems independently and communicate technical issues clearly—both verbally and in writing.
Strong collaboration skills and a team-oriented mindset.
Self-motivated and capable of working with minimal supervision.
Exposure to Lean Manufacturing and Six Sigma methodologies is a plus.
Willingness and ability to work 12-hour shifts, including nights, weekends, and holidays, in support of a 24/7 manufacturing operation.
Comfortable working in a clean room environment and adhering to safety protocols.
Ability to wear personal protective equipment (e.g., hard hats, safety shoes, safety glasses, ear plugs) as required.
Willingness to travel occasionally (less than 5%).
Locations USA - GA - Social Circle - Hwy 278
Salary U.S. Base Salary Range: $56,000.00 - $88,000.00
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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