Senior Technical Operations Engineer - Reagent Manufacturing

biotechne; Minneapolis (MN); On-site; USD 101,000 - 166,000; Full time

Job summary

Bio-Techne Minneapolis site is the company's largest Reagent Operations Capability Center and Focused Factory, manufacturing and shipping reagents and related research products. The Senior Process Engineer - Reagent Manufacturing strengthens manufacturing capability by building process understanding, resolving prioritized technical gaps, and improving robustness, quality, and manufacturability.

You will serve as SME for reagent preparation, liquid handling, mixing, formulation, and filtration,

Responsibilities

• Lead process-engineering support for prioritized technical gaps within current manufacturing processes.
• Evaluate overall process capability by assessing materials, equipment, scale, process parameters, operating methods, sources of variation, and process outputs.
• Build deeper process understanding and recommend improvements that increase robustness, repeatability, quality, and manufacturability.
• Serve as the technical subject matter expert for reagent preparation, liquid handling and transfer, mixing, formulation, and filtration.
• Apply process-engineering principles to mixing scale-up, including equipment selection, operating ranges, and confirmation of expected process performance.
• Evaluate filtration requirements, including filter selection, sizing, operating conditions, compatibility, capacity, and expected process performance.
• Assess process and equipment cleanability and recommend controls that support appropriate bioburden control.
• Lead technical assessments of manufacturing issues, determine likely causes, define appropriate engineering studies, and recommend sustainable corrective actions or improvements.
• Apply process-engineering methods to cell culture, purification, and other manufacturing processes, partnering with area technical experts as appropriate.
• Identify additional process-improvement opportunities through process observation, technical analysis, and manufacturing experience.
• Evaluate the suitability of existing equipment for current and changing manufacturing needs.
• Define process and user requirements and support the selection, sizing, or improvement of equipment used in major manufacturing unit operations.
• Participate in vendor reviews and testing, commissioning, and qualification activities to confirm that equipment meets defined process requirements.
• Troubleshoot equipment and process interactions when equipment performance affects process reliability, product quality, or manufacturing execution.
• Partner with Facilities, Manufacturing Engineering, Automation, and equipment suppliers to convert process needs into practical equipment solutions.
• Assess process, equipment, scale, and facility readiness when products, processes, or equipment are introduced or changed.
• Review available product and process knowledge with R&D, development teams, and process owners to identify technical gaps, assumptions, and risks.
• Translate available process knowledge into clear manufacturing requirements.
• Define engineering studies and acceptance criteria, analyze results, and provide technical readiness recommendations.
• Support implementation activities when additional technical evaluation is needed to confirm manufacturing readiness.
• Work closely with R&D, Manufacturing, Quality, Facilities
• Lead process-engineering support for prioritized technical gaps within current manufacturing processes.

Job description

By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

$100,800.00 - $165,600.00

Position Summary

The Bio-Techne Minneapolis site is the company's largest Reagent Operations Capability Center and Focused Factory, manufacturing and shipping recombinant proteins, antibodies, ELISA kits, Luminex assays, cell culture media, protein analysis instrument reagents, and other products used in academic research, biopharma drug discovery, quality control, and related applications. The Senior Process Engineer - Reagent Manufacturing strengthens the site's manufacturing technical capability by building process understanding, resolving prioritized technical gaps, and improving the robustness, repeatability, quality, and manufacturability of existing processes. The role serves as the technical subject matter expert for reagent preparation, liquid handling and transfer, mixing, formulation, and filtration. The engineer evaluates how materials, equipment, scale, process parameters, and operating methods work together to determine overall process capability. This includes evaluating cleanability and recommending process and equipment practices that support appropriate bioburden control. The role also provides process-engineering support for cell culture, purification, and other manufacturing processes, partnering with area technical experts when specialized process knowledge is required. The engineer leads technical assessments and engineering studies, defines process and equipment requirements, and recommends sustainable improvements. The role also supports manufacturing readiness when products, processes, equipment, or scale are introduced or changed and may be deployed to major process-engineering issues across Minneapolis manufacturing operations. Manufacturing owns routine execution, and Quality retains approval authority.

Key Responsibilities

Process Engineering and Technical Support

• Lead process-engineering support for prioritized technical gaps within current manufacturing processes.
• Evaluate overall process capability by assessing materials, equipment, scale, process parameters, operating methods, sources of variation, and process outputs.
• Build deeper process understanding and recommend improvements that increase robustness, repeatability, quality, and manufacturability.
• Serve as the technical subject matter expert for reagent preparation, liquid handling and transfer, mixing, formulation, and filtration.
• Apply process-engineering principles to mixing scale-up, including equipment selection, operating ranges, and confirmation of expected process performance.
• Evaluate filtration requirements, including filter selection, sizing, operating conditions, compatibility, capacity, and expected process performance.
• Assess process and equipment cleanability and recommend controls that support appropriate bioburden control.
• Lead technical assessments of manufacturing issues, determine likely causes, define appropriate engineering studies, and recommend sustainable corrective actions or improvements.
• Apply process-engineering methods to cell culture, purification, and other manufacturing processes, partnering with area technical experts as appropriate.
• Identify additional process-improvement opportunities through process observation, technical analysis, and manufacturing experience.

Equipment and Process Integration

• Evaluate the suitability of existing equipment for current and changing manufacturing needs.
• Define process and user requirements and support the selection, sizing, or improvement of equipment used in major manufacturing unit operations.
• Participate in vendor reviews and testing, commissioning, and qualification activities to confirm that equipment meets defined process requirements.
• Troubleshoot equipment and process interactions when equipment performance affects process reliability, product quality, or manufacturing execution.
• Partner with Facilities, Manufacturing Engineering, Automation, and equipment suppliers to convert process needs into practical equipment solutions.

Process Readiness and Implementation Support

• Assess process, equipment, scale, and facility readiness when products, processes, or equipment are introduced or changed.
• Review available product and process knowledge with R&D, development teams, and process owners to identify technical gaps, assumptions, and risks.
• Translate available process knowledge into clear manufacturing requirements.
• Define engineering studies and acceptance criteria, analyze results, and provide technical readiness recommendations.
• Support implementation activities when additional technical evaluation is needed to confirm manufacturing readiness.

Cross-Functional Partnership

• Work closely with R&D, Manufacturing, Quality, Facilities, Manufactur