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This position will be responsible for writing and reviewing documents that support Manufacturing, Quality Control, and CMC Regulatory Departments. As a Process Controls & Validation Engineer, a typical day might include the following:Working with a multi-functional team to support technology transfer and scale-up of processes from Regeneron’s process development teamAnalyzing R&D, late-stage characterization studies, and historical manufacturing data to support process control programs.
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This position is part of the Quality Control, QC Chemistry, Drug Product Testing team. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies.
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Using PLCs and HMIs to provide technical support and solutions to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices. Have advanced in PLC/HMI programming and troubleshooting utilizing Allen-Bradley Studio 5000 / FactoryTalk View SE and Siemens Simatic Step 7 / WinCC which involve the use of batch programming (S-88), B&R Automation Studio, and PID control.
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Leading Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICH E6 R2. The GDQM (GCP) QML will engage with key stakeholders, build strategic partnerships working and liaising with study teams, relevant functions and other GDQ functions to lead risk-based quality management activities on all Regeneron-sponsored clinical trials, inclusive of issue management and providing continuous support of inspection readiness.
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