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Skills
Contract Research Organization (CRO)unmatched
Design Failure Mode and Effects Analysis (DFMEA)unmatched
Documentationunmatched
Manufacturing Engineeringunmatched
Manufacturing Operationsunmatched
Operational Supportunmatched
Operations Processesunmatched
Process Failure Mode and Effects Analysis (PFMEA)unmatched
Process Improvementunmatched
Process Validationunmatched
Production Systemsunmatched
Riskunmatched
Risk Analysisunmatched
Risk Managementunmatched
Standard Operating Procedures (SOP)unmatched
Technical Writingunmatched
Description
Katalyst CRO seeks a Senior Manufacturing Engineer to support manufacturing operations through process improvement, technical documentation, and risk management in a regulated production environment.This role emphasizes revising and maintaining SOPs, work instructions, and process docs, with a strong focus on risk assessment using PFMEA/DFMEA and validation activities (IQ, OQ, PQ). Experience with CSV is a plus in a high-volume setting.#J-18808-Ljbffr