Edwin Alexander Abrew Email & Phone Number

My most recent experience is as an Equipment & Computer Systems Validation (CSV) professional. I have a post college, three-year practice as a Research Associate with LifebankUSA, an AABB accredited cord blood banking lab where I gained foundational experience in placental CD-34 stem cell research, equipment and procedure development of cell culture, suspension, isolation, identification, quantification and cryogenic cell preservation and storage methods. Following Lifebank’s acquisition by Celgene I was promoted to Research Associate II and trained in commercial tissue engineering and production, environmental monitoring, microbiological and product viability, sterility and endotoxin testing. This progressed to a proficiency in commercial Class 1000 cleanroom processes from three years with Dendreon as a Cell Processing Associate II working in clinical trials of an innovative cellular immunotherapy called sipuleucel-T and advancement to a Manufacturing Associate II and Trainer role following FDA commercial approval of Provenge™. My prior tissue engineering experience extended into a research project with Lifecell developing a Human Adipose Tissue product. I am well versed in lab information management systems (LIMS) as part of equipment IQ OQ PQ, repair, maintenance, calibration, and validation as well as prototype modification, installations and systems development from over five years as a Field Service Engineer with RAININ, Mettler-Toledo (MT) and Prototype Installation Engineer with Siemens. During this field experience I performed a simultaneous and very successful Sales role with Rainin and MT and secured a NYC Territory Sales Manager role with Genesee Scientific. My technical experience was complimented by ongoing Quality Assurance roles that include writing procedural and equipment SOPs, CAPAs and conducting product, process and equipment failure investigations Root Cause Analysis and consequent correctional development of production research scale-up projects as a pilot plant technician responsible for the operation, monitoring, maintenance of research fuel reactors with EMRE. I successfully completed a GC Software and Hardware training course at Agilent University for Field Service at the beginning of the pandemic, I then consequently secured my most recent consulting position with Janssen. Although extensive and diverse, my background makes me the well-rounded professional I am today.

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  Validation Specialist

  The Janssen Pharmaceutical Companies Of Johnson & Johnson