Technician-Bioreactor/Downstream
Elanco
16 days ago
On-site
Fort Dodge, IA
Operations
Your Role: Operations Specialist – Biological Manufacturing
As an Operations Specialist – Biological Manufacturing, you will support vaccine production operations by performing aseptic manufacturing activities in compliance with cGMP and safety standards. You will focus on operational efficiency, equipment readiness, product quality, and continuous improvement.
Responsibilities:
- Perform aseptic manufacturing activities (weighing, measuring, sampling, calculations, batch record execution) in compliance with cGMP
- Operate, monitor, troubleshoot, and support production equipment and electronic inventory management systems
- Conduct in-process quality checks, environmental monitoring, and cleaning per written procedures
- Support deviation reporting, SOP updates, training completion, and documentation in electronic systems
- Participate in LEAN and continuous improvement initiatives to enhance manufacturing operations and workflow efficiency
Minimum qualifications:
- Education: Bachelor’s degree in Microbiology (or related) OR Associate’s degree + 2 years’ experience OR High School Diploma/GED + 4 years’ relevant experience
- Experience: Manufacturing/biological/pharmaceutical/regulated production experience (preferred)
- Skills: Strong attention to detail and compliance mindset; ability to operate manufacturing equipment and follow batch production documentation
Preferred qualifications:
- cGMP/aseptic manufacturing experience
- Knowledge of biological production equipment (e.g., fermentation, centrifuges, concentration units)
- ERP and electronic inventory management system experience
- Experience writing SOPs, deviations, or supporting quality documentation
- Familiarity with LEAN manufacturing and continuous improvement practices
As an Operations Specialist – Biological Manufacturing, you will support vaccine production operations by performing aseptic manufacturing activities in compliance with cGMP and safety standards. You will focus on operational efficiency, equipment readiness, product quality, and continuous improvement.
Responsibilities:
- Perform aseptic manufacturing activities (weighing, measuring, sampling, calculations, batch record execution) in compliance with cGMP
- Operate, monitor, troubleshoot, and support production equipment and electronic inventory management systems
- Conduct in-process quality checks, environmental monitoring, and cleaning per written procedures
- Support deviation reporting, SOP updates, training completion, and documentation in electronic systems
- Participate in LEAN and continuous improvement initiatives to enhance manufacturing operations and workflow efficiency
Minimum qualifications:
- Education: Bachelor’s degree in Microbiology (or related) OR Associate’s degree + 2 years’ experience OR High School Diploma/GED + 4 years’ relevant experience
- Experience: Manufacturing/biological/pharmaceutical/regulated production experience (preferred)
- Skills: Strong attention to detail and compliance mindset; ability to operate manufacturing equipment and follow batch production documentation
Preferred qualifications:
- cGMP/aseptic manufacturing experience
- Knowledge of biological production equipment (e.g., fermentation, centrifuges, concentration units)
- ERP and electronic inventory management system experience
- Experience writing SOPs, deviations, or supporting quality documentation
- Familiarity with LEAN manufacturing and continuous improvement practices