Senior Manufacturing Engineer Diagnostics
VitalBio
Lead diagnostics manufacturing engineering at Vital Bio onsite, combining automation expertise with hands-on process development in a cGMP environment.As a Senior Manufacturing Engineer, you will own complex programs from development through scale-up and sustaining operations. You will guide technology transfers, optimize consumable and instrument processes, and apply structured problem solving. Cross-functional collaboration with R&D, assay development, Quality, Manufacturing, and Supply Chain supports verification, validation, and production needs.Key Responsibilities:
Lead manufacturing engineering programs and process strategyTransfer technologies into cGMP manufacturingOptimize reagent and molded-component assembly processesDevelop automation strategies and equipment selectionsGuide investigations, corrective actions, and continuous improvementRequirements:
Bachelor’s degree in a STEM discipline8+ years in regulated manufacturing engineeringExperience leading process development and production scale-upKnowledge of cGMP, ISO 13485, and validationProficiency with pFMEA, SPC, DOE, and data analysisBring technical ownership, automation knowledge, and validation expertise to Vital Bio’s diagnostic manufacturing programs.
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Lead manufacturing engineering programs and process strategyTransfer technologies into cGMP manufacturingOptimize reagent and molded-component assembly processesDevelop automation strategies and equipment selectionsGuide investigations, corrective actions, and continuous improvementRequirements:
Bachelor’s degree in a STEM discipline8+ years in regulated manufacturing engineeringExperience leading process development and production scale-upKnowledge of cGMP, ISO 13485, and validationProficiency with pFMEA, SPC, DOE, and data analysisBring technical ownership, automation knowledge, and validation expertise to Vital Bio’s diagnostic manufacturing programs.
#J-18808-Ljbffr
Vacancy posted 1 hour ago
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