Process Development Engineer
Current• Test method development, qualification and validation of analytical methods involving oxygen sensitive proteins, enzymes, oligos and high risk reagents.• Quality control for SBS reagents & decoder pool manufacturing including process investigation, evaluation, failure analysis and process improvement.• VSA support for array manufacturing: mapping of decoder pool and bead pool manufacturing process. Identified problems/gaps in the process while providing solutions and analytical tools• Protein identification, characterization, quantification and analysis using analytical instrumentation: UHPLC, UV-vis, ion chromatography, flow cytometry, fluorescence spectroscopy (Spectramax/Biotek), qPCR, Gel Electrophoresis• Strong technical scientific writer and presenter with the ability to perform research, problem solving and development work independently• Project management and leadership though collaborative projects• Laboratory manager for 7+ years; duties included oversight of instrument maintenance and troubleshooting instrumentation. • Validation, calibration and equipment engineering for laboratory instrumentation including onboarding, calibrating (KCPs) and validating equipment using EAM and ValGenesis software. • Drafting and executing validation protocols, IOQ/PQs, validation reports and risk assessments (SRA) in ValGenesis.• Implement manufacturing procedures to produce high quality biochemical reagents for internal and external customers using computerized transactions.• Work with the New Product Improvement team to identify process discrepancies, resolve technical issues and improve the Standard Operating Procedures of a complex automated system.• Perform functional testing, calibrating, and troubleshooting of analytical equipment such as a Spectrometer, ICS, HPLC/UPLC.• Comply with all requirements of the Illumina Quality System, all manufacturing, regulatory and safety requirements including GMP and GLP practices.
