Senior Technical Operations Engineer – Reagent Manufacturing
Listed on 2026-08-30
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Engineering
Process Engineer, Validation Engineer, Quality Engineering, Manufacturing Engineer -
Manufacturing / Production
Validation Engineer, Quality Engineering, Manufacturing Engineer
Position Summary:
Senior Process Engineer – Reagent Manufacturing provides technical process-engineering expertise to strengthen manufacturing capability—improving robustness, repeatability, quality, and manufacturability of existing processes for reagent manufacturing.
Key Responsibilities:- Lead process-engineering support for prioritized technical gaps; assess overall process capability (materials, equipment, scale, parameters, operating methods, variation, outputs).
- Serve as SME for reagent preparation, liquid handling/transfer, mixing, formulation, and filtration.
- Support mixing scale-up (equipment selection, operating ranges, performance confirmation) and filtration (selection, sizing, operating conditions, compatibility, capacity).
- Assess and improve process/equipment cleanability to support bioburden control.
- Lead technical assessments and engineering studies; define requirements/acceptance criteria and recommend sustainable corrective actions.
- Apply process engineering to cell culture, purification, and related processes as needed.
- Evaluate equipment suitability; support equipment selection/improvements; participate in vendor reviews/testing/commissioning/qualification; troubleshoot equipment–process interactions.
- Support process readiness and implementation for introductions/changes; translate knowledge into manufacturing requirements.
- Partner cross-functionally (R&D, Manufacturing, Quality, Facilities, Engineering, Automation) and communicate risks/study results; capture technical basis to maintain process knowledge.
- Bachelor’s degree in engineering (chemical/biochemical preferred).
- 3+ years relevant process-engineering experience (5+ preferred) in pharma/biopharma/biotech/reagent/diagnostic manufacturing.
- Demonstrated liquid-processing unit operations experience (mixing, formulation, filtration, liquid handling/transfer).
- Experience with equipment selection, process requirements, commissioning/qualification, or troubleshooting.
- Regulated/controlled quality system experience preferred.
- Process/equipment introduction or significant modification experience preferred; cell culture/purification exposure preferred.
Process capability evaluation; cleanable processing/bioburden control; define studies and acceptance criteria; structured problem-solving/root-cause analysis; translate tech transfer needs into operating/equipment requirements; communicate clearly; work across site functions and quality documentation/approval systems; manage multiple priorities.
Benefits (as stated):- Competitive insurance (medical, dental, vision, life, short/long-term disability, pet, legal/d) and 401k/ESPP/HSA/FSA.
Onsite role supporting office, laboratory, and manufacturing activities at the Minneapolis site; controlled environments may require PPE/gowning.
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