Senior Reagent Manufacturing Engineer - Process Lead

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

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,