Chemical Engineering Quality Control

ABHISHEK ARUN DATAR

Newark, NJ *************@*****.*** 862-***-****

EDUCATION

New Jersey Institute of Technology 01/2021 – 12/2023 Master of Science, Chemical Engineering GPA - 3.4

Shivajirao S Jondhale College of Engineering, University of Mumbai 08/2014 – 05/2019 Bachelor of Science, Chemical Engineering

WORK EXPERIENCE

Validation Engineer Trainee, Validation Associates LLC, VA - Remote 06/2024 - Present

● Assist in designing and implementing validation protocols (IQ, OQ, PQ) and developing validation master plans, process flow diagrams, and standard operating procedures to ensure compliance with FDA guidelines and GxP standards.

● Support the creation and management of validation documentation, including Validation Plan Summaries, Test Plans, URS, FRS, RTM, and Qualification Protocols, while documenting testing defects and contributing to equipment and software qualification processes. Product Development Scientist - CO-OP, Tris Pharma, NJ 06/2022 – 12/2022

● Performed preformulation and formulation studies in manufacturing processes for ADHD MEDICATION, optimizing pilot-scale reactor parameters for MPH resin production, resulting in enhanced yield, product quality, and reduced cycle times.

● Conducted root cause analyses for process deviations, including fluid bed reactor issues, implementing corrective measures that improved operational efficiency by 20%.

● Leveraged data-driven approaches to troubleshoot production variances, applying process optimization techniques to improve consistency and minimize disruptions.

● Streamlined production workflows to drive cost efficiency, maximize throughput, and ensure consistent performance across key equipment, such as automated filling machines for ADHD medication.

● Led the qualification of new equipment and raw materials, ensuring alignment with regulatory standards and manufacturing requirements.

● Proactively monitored process performance, optimizing cycle times and operational efficiency while maintaining rigorous quality control.

● Authored and maintained comprehensive operating procedures and equipment specifications to ensure consistency, regulatory compliance, and adherence to GMP standards.

● Partnered with cross-functional teams in QA, validation, AR&D, and manufacturing operations to support continuous improvement initiatives, driving factory performance enhancements and operational excellence. Process Engineer, Puraj Chemicals - India 06/2019 – 12/2020

● Boosted output by 20% in β-amides manufacturing by optimizing the methylene dichloride washing cycle, significantly improving efficiency.

● Collaborated with Quality Control to ensure ISO 9001, GLP, and GDP compliance and meet customer demands by analyzing critical quality parameters using TLC, boiling point, and melting point methods.

● Oversaw and troubleshot batch reactors, centrifuges, pumps, and dryers while maintaining wastewater pH, BOD, and COD levels within regulatory standards.

● Directed field operators and technicians in equipment commissioning, problem-solving, and startup/shutdown processes, while enhancing safety protocols and updating SOPs for operational excellence, cGMP adherence, and regulatory compliance. Process Engineer, Sitaram Chemicals – India 06/2016 – 07/2017

● Led the manufacturing of Pigment Yellow using the diazotization process, overseeing unit operations including blending, filter press, and press cake handling.

● Managed safe storage of ammonium nitrate, ensuring compliance with safety regulations and passing government audits. Maintained boiler operations for efficient production.

● Collaborated with QA lab to verify that pigments met quality standards and customer requirements. Coordinated packaging to align with client specifications.

● Optimized production costs by monitoring raw material inventory and implementing cost-effective processes, resulting in improved overall production efficiency.

PROJECTS

Detection of 1,4 Dioxane in water and soil samples from Ringwood, NJ superfund site

● Led a multidisciplinary team to analyze contamination using GCMS, including collecting and testing water and soil samples from multiple sites and conducting detailed lab experimentation.

● Gathered and analyzed data to assess contamination levels and detect impurities. SKILLS

Software: Microsoft Office (Word, Excel, PowerPoint), Polymath, MATLAB

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