Daniel Berke
Location
Miami, FL
South Setauket, NY
Education
U
University at Buffalo
September 2017 - August 2021
degree
Master's
major
Chemical Engineering
S
Suffolk County Community College
Work Experience
N
New Vision Pharmaceuticals
Validation Engineer
Tamarac, FL, US
January 2023 - present
company
New Vision Pharmaceuticals
title
Validation Engineer
overview
- Manager - Luis "Mak" Hernandez
- Analyzed deviations to perform investigations in a BSF ISO 8 & 7 clean room facility of aseptic processes & sterile products
- Wrote MBRs (Initial & revision) based on change controls and CAPAs, through an eQMS at a rapid pace on short notice
- Generated protocols (Initial and revisions) for Process qualifications (e.g. Steam In Place, Stability Chambers, Facility Environmental Monitoring
- Independently managed delivery of varied documents types, due on an intermediate time line, concurrently
- Provided technical knowledge to departments and coworkers (i.e. Chemistry & Mathematics
K
Kelly Services
Chemical Process Engineer I
Troy, MI, US
July 2022 - December 2022
A
ADT Solar Formally SUNPRO
Call Center Agent Remote
Mandeville, LA, US
January 2022 - July 2022
U
University at Buffalo
Buffalo, NY, US
January 2020 - August 2021
Skills
AsepsisAuto Dialer (Communication Software)BiotechnologyCall CentersCarrying out AssessmentsCell CulturesChange ControlChemical EngineeringChemical ProcessChemistryCommercial SupportCultural ActivitiesCuriosityEnvironmental MonitoringGood Manufacturing PracticesJava (Programming Language)JMP (Statistical Software)Knowledge of CleanroomsKnowledge of MathematicsKnowledge of StatisticsManufacturingMedicinal ChemistryMicrosoft ExcelMicrosoft OfficeMicrosoft PowerPointMicrosoft WordPharmaceuticalsPhotovoltaicsProblem SolvingProcess EngineeringQuality AuditingQuantificationResearch SkillsSales PromotionSAS (Software)Team WorkingTechnical SkillsTelephone Skills