Responsibilities: Engage with both Corporate IT and IOPS IT to ensure IT processes and procedures meet Regeneron's Quality System requirements. Participate and support the Quality Risk Management (QRM) principles in the formal and inform...
Responsibilities: Assist in the planning and execution of labware validation activities, including equipment, software, and system qualification. Support the preparation and execution of validation protocols, including Installation Quali...
Responsibilities: Develop and execute clean room validation protocols (IQ, OQ, PQ) to ensure compliance with industry standards (ISO 14644, EU GMP Annex 1, FDA, USP 797/800). Perform particle count testing, air velocity/HEPA filter integ...
Responsibilities: Previous experience in inhalation drug delivery. Has broad knowledge of medical device development, design controls and risk management. Led and managed development of DHF (design history file) deliverables for medical...
Responsibilities: Participate on teams of internal resources in delivery of CSV projects. Author functional requirements specifications that are complete, accurate, and testable. Author system Risk Assessments, 21 CFR 11 Assessments, an...