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Associate MSAT Engineer Regeneron - 3.6 Troy, NY Job Details $62,355 - $92,400 a year 1 day ago Benefits Health insurance Dental insurance Paid time off Vision insurance 401(k) matching Qualifications Quality control corrective actions Performance monitoring Data integrity assurance Statistics Technical engineering Content creation for technical audiences Production data analysis Defect resolution root cause analysis Procedural guides Team leadership Defect analysis Technical writing experience within manufacturing Production deviation management Gap analysis Good documentation practices (GDP) Mid-level Internal investigations Manufacturing standard operating procedures Manufacturing facility experience Technology transfer (scale-up process) Compliance documentation Data interpretation Collaboration with manufacturing teams Technical troubleshooting support Factory process monitoring Production batch record review Root cause analysis Standard operating procedures (SOPs) Cross-functional communication Engineering validation

Full Job Description Essential Duties and Responsibilities:

Support internal and external technology transfer activities, including participation in facility fit assessments and high-level gap assessments. Generate, review, and support documentation associated with technology transfer, including process descriptions, master plans, reports, and technical documents. Provide technical support to manufacturing operations during start-up, engineering runs, validation, and routine manufacturing. Leverage engineering principles during problem solving and process support. Review manufacturing documentation generated by receiving sites, including batch records, automation recipes, SOPs, and change documentation. Gather, trend, and analyze process data to support process understanding and ongoing process performance monitoring. Participate in investigations and deviation assessments and support identification of root causes and corrective actions. Apply engineering principles to the development and execution of manufacturing support activities. Analyze data using a combination of statistics, engineering principles and other techniques to gain insight into manufacturing support activities. Work effectively in cross-functional teams to support timely execution oSAT deliverables. Ensure activities are performed in accordance with cGMP. May lead others. Perform other duties as assigned. Travel to internal manufacturing sites or external partners as required (