Rob Eleuterio
Senior Manager, Validation, Compliance Group
Robert has 10+ years of experience in quality systems, project coordination, and laboratory operations in the biotechnical, pharmaceutical, and medical device industries including experience in external quality, vendor communication, gene therapy/RNA therapy /Vaccines and emerging personalized medicine pharma. Extensive experience in laboratory design and validation from medical device quality and R&D operations, pharmaceutical QA/QC, and (petro)chemical. Roles include drafting of significant deliverables, test executions, design verification, QMS managements, complaint handling, and cross-functional team environments. Experience with Analytical Instrument Qualification, laboratory compliance activities including auditing and ownership of instrumentation and test method validation per USP and CFR requirements. Experience with laboratory and mfg investigations, quality trending, OOS and OOT, investigations, and CAPA activities. Ability and familiarity to perform instrument risk classification, FMEA’s, quality trending of data output during validation activities, and build USR’s from stakeholders needs.
