Tibco Spotfire Process Engineer

Janki Patel

978-***-**** **********@*****.*** linkedin.com/in/jankiptl

Solutions-driven Process Engineer with experience in cross-functional project management involving lean development, operational improvements, manufacturing excellence, documentation, CMO product and process updates. Seeking prospects to transform company practices into fresh, cost-effective solutions driving business growth. SKILLS

Certifications: Lean Six Sigma Yellow Belt (CSSYB), Lean Six Sigma White Belt (CSSWB) Technical: Project Management, Problem Solving, Cost Reduction, Process Improvement, Root Cause RCA, DMAIC, SPC, KPI, 5Why, Fishbone, Capacity Analysis Operations: MS Excel, MS Project, Apache Geode, Phenix, Qlik Data Mart, TIBCO Spotfire, Digital Huddle, Statistica, Qlik Sense, SAP, LIMS, DeltaV, Syncade, NOVA, Vi-CELL, PFS, Baan, JMP PROFESSIONAL EXPERIENCE

Process Engineer (MSAT) Sanofi Genzyme May 2021 - Present

• Analyzing manufacturing process descriptions and product trends using Spotfire and Digital Huddle to recommend change and/or additional experimentation to improve product quality, recovery, productivity and overall efficiency

• Performing Continued Process Verification (CPV) during campaign execution and facilitating stakeholder reviews to deliver process performance results on data trends and deviations

• Documenting investigational and change control reports for Tier 2/3 Extractable & Leachable (E&L), and Fit For Use project outcomes followed by periodic CMO partner reviews to examine process performance and root cause analysis

• Collaborating with CMO, MSAT Engineering, Manufacturing and Quality teams to define process control strategies and perform risk assessment following Quality by Design QbD principles Upstream Bioprocess Associate Bristol Myers Squibb March 2020 - May 2021

• Enhanced the production process efficiency by implementing a new glucose nutrient feeder mechanism resulting in cost and time reduction along with reduced raw material consumption

• Monitored critical operating parameters to ensure standard operation procedures and supported production execution schedules for commercial, clinical and development phases

• Strategized inventory planning for small scale operations resulting in less material misses and short pick times

• Supported manufacturing process preparation for bioreactors and autoclave operations, mammalian cell transfection, protein purification, along with Syncad generated LIMS sampling for product development

• Skilled in protein expression from mammalian cells (CHO cells) using technologies for sampling in NOVA and Vi-cell Intern, Production Quality Control Engineering Benchmark Electronics Inc. March 2019 - March 2020

• Performed operational time studies analysis to integrate, develop and document a balanced ITAR production process

• Worked with high-powered automotive manufacturing applications to test product quality and gauge measurements

• Participated in production and quality approval processing on procurement and route tracking, worked with BAAN and PFS to track operation records and accomplished analytical and project-oriented goals Medical Manufacture Associate III Maquet Getinge Group Aug 2015- May 2018

• Performed Analytical studies on assay (chromatography, HPLC) and prepared method validation report for further processing with the QA team based on the standard operating procedures (SOP)

• Collaborated with Research and Development team to inspect covering stents and balloons using Polariscope and Microscope with critical details to attributes

• Reviewed work instruction batch records followed by equipment setup to perform manufacturing process calibration

• Worked with SOP, cGMP, GDP and cleanroom environment, covered assembly line inspection stents and examined processes using UV/Vis Spectrophotometer

EDUCATION

Bachelor of Biological Science, University of Massachusetts (Lowell, MA) May 2020

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