Experienced Engineering professional with more than eight years of industrial & five years of academic research experience; can manage teams by applying organizational psychology, demonstrated history of problem solving while working in the Biopharma, bioenergy & beverage industry. Expert in Computerized system Validation, process development & manufacturing with a strong understanding of cGMP principles supporting FDA & EMA guidelines. Have a successful history of managing and building teams in international settings through various roles for both Brownfield & Greenfield projects in USA, India & European CMOs, ability to conceptualize complex problems into feasible solutions. Skilled in commissioning, qualification, Validation & manufacturing with Bachelor's & Master's degree in Chemical Engineering
TOP SKILLS
► software & programming languages: aspen plus, imagej, gwyddion, dev c++, power point,excel, one attention (contact angle), c++ (object oriented computation), visio drawing► laboratory techniques: contact angle by sessile droplet method, scanning electron microscopy (sem), tem, edx,sputter coating, sonication transducers, atomic force microscopy (afm), uv spectroscopy, xrd, titrations, analytical methods► biopharma: 21 cfr, usp, fda, ema, fssai, hc guidelines, change controls, deviations, amendment, capa, root cause & analysis, process & equipment standardization, equipment & computerized system validation, filter validation, device controls, extraction & leaching studies, tech transfer, combination device, organic & analytical chemistry, container closures, change controls, single use closed systems, tech transfer, process controls, amendments, fat & sats qualification, commissioning & decommissioning, etc.
