Experience

Cook MyoSite

• United States
• Biotechnology Research
• 100 - 200 Employee

• Technical Services Validation Engineer II, Process

  • Feb 2022 - Present

  Pittsburgh, Pennsylvania, United States

• Technical Services Validation Engineer

  • Feb 2019 - Feb 2022

  Greater Pittsburgh Area • Develop process validation strategy for manufacturing processes • Assist in development of QTPPs, CQAs and CPPs for Cellular Therapy Manufacturing Processes • Identify and document process controls and key performance indicators of manufacturing processes • Develop process validation protocols in accordance with regulatory requirements • Conduct process validation and verification studies in accordance with current industry standards and guidelines for the qualification and… Show more • Develop process validation strategy for manufacturing processes • Assist in development of QTPPs, CQAs and CPPs for Cellular Therapy Manufacturing Processes • Identify and document process controls and key performance indicators of manufacturing processes • Develop process validation protocols in accordance with regulatory requirements • Conduct process validation and verification studies in accordance with current industry standards and guidelines for the qualification and validation of manufacturing processes • Lead and coordinate process validation projects ensuring proper execution/documentation of test results, and compilation of validation packages • Develop qualification protocols (IQ, OQ, PQ) for systems supporting the process such as equipment and instruments • Execute the qualification studies and generate scientifically sound summary reports. • Assist in development of SOPs, work instructions, job aids and production batch records • Participate in risk management activities for proposed changes to manufacturing process and develop verification strategy by coordinating with subject matter experts • Compile and analyze process performance data and generate technical reports • Support and/or author in-operation/end-user investigations pertaining to validated systems



Cody Laboratories, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• New Product Development Validation Engineer

  • Nov 2016 - Jan 2019

  Cody, Wyoming * Developing IQ Protocols, OQ Protocols, PQ Protocols, Cleaning Verification Protocols and Commissioning Data. *Executing Approved IQ/OQ and PQ Qualification Process. *Analyze statistically significant Data obtained while executing said Protocols. *Preparing Summary Reports using IQ/OQ/PQ and Commissioning monitoring and test data. *Participating in Lock Out, Tag out and other safety programs. *Reviewing, Amending and Writing applicable SOPs. *Preparing Cleaning Validation… Show more * Developing IQ Protocols, OQ Protocols, PQ Protocols, Cleaning Verification Protocols and Commissioning Data. *Executing Approved IQ/OQ and PQ Qualification Process. *Analyze statistically significant Data obtained while executing said Protocols. *Preparing Summary Reports using IQ/OQ/PQ and Commissioning monitoring and test data. *Participating in Lock Out, Tag out and other safety programs. *Reviewing, Amending and Writing applicable SOPs. *Preparing Cleaning Validation Protocols and SOPs. *Run Cleaning Engineering and Development Studies as a part of preparing CVPs. *Part of Product Development teams and ensuring timely completion of projects. * Assist Process Engineering as a part of product development teams. * Act as an SME and Production Engineer for GMP CIP Processes for API manufacturing. * Creating and Developing a Cleaning Validation Matrix and Plan to identify worst case product residues across current product portfolios. * Conduct pFMEAs, HAZOPs and Risk Assessments as a part of Project Teams. *Participating in Internal Audit and cross functional teams. *Ensuring cGMP and SOP compliance wherever applicable. * Interface with Process Engineering in order to perform Process Validation for new Manufacturing Processes. * Conduct Root Cause Analysis(RCA) and Investigations into Manufacturing Atypical Events as and when applicable. *Writing and Executing Process Validation Documentation for New Products and Processes. Show less



Nevakar Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Research and Development Intern

  • Jul 2016 - Oct 2016

  Bridgewater, New Jersey • Ensured that Lab activities conform to GLP standards. • Support Formulation department as per requirement. • Calibrating all the Laboratory equipment as per requirement and schedules. • Interact with Vendors and Suppliers for all Chemical and Laboratory Equipment Needs. • Assist in Facility Management. • Assist Analytical Team in testing using KF Titration and Waters HPLC systems.



Aurex Laboratories LLC

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Engineering Associate

  • Sep 2015 - Apr 2016

  East Windsor,New Jersey *SOP Preparation in order to ensure compliance with CGMP. *Preparation and execution of IQ/OQ/PQ for various processes and equipment in a solid oral dosage manufacturing setting. *Creating a schedule and SOP for Preventive and Breakdown Maintenance of Equipment. *Communicating with Vendors and External Service Providers in order to accurately cover the PM and Calibration schedule. *Maintaining a controlled environment so that the process can operate smoothly as per ISO 8 Clean room… Show more *SOP Preparation in order to ensure compliance with CGMP. *Preparation and execution of IQ/OQ/PQ for various processes and equipment in a solid oral dosage manufacturing setting. *Creating a schedule and SOP for Preventive and Breakdown Maintenance of Equipment. *Communicating with Vendors and External Service Providers in order to accurately cover the PM and Calibration schedule. *Maintaining a controlled environment so that the process can operate smoothly as per ISO 8 Clean room Standards. * Ensuring that the process runs smoothly in order to create and maintain the product as per customer expectations. * Prepared Facility Validation documents, Quality related documents and the Basis of Design for the facility. * Assist Formulation in conducting Bench Trials and scale up activities. * Reviewing Technical GMP Documents like MBRs, SOPs and Change Control Procedures. * Writing Technical documents like SOPs, CAPAs, NOIs, Change Control Procedures and Root Cause Analysis(RCA) *Entering and Managing Assets using a QMS (QT9) Show less



Rutgers University

• United States
• Higher Education
• 700 & Above Employee

• Graduate Research Student

  • Jan 2015 - Sep 2015

  New Brunswick,New Jersey Research in the field of Industrial Waste Water treatment using natural Chitosan and Alginate Particles as resin to treat the chemical ions in waste water.



Aditya Birla Group

• India
• Executive Offices
• 700 & Above Employee

• Chemical Process Engineer

  • Jul 2013 - Aug 2014

  Haveri Area, India Chemical Engineer at Grasim Industries Ltd, Textile Division of the Aditya Birla Group. My day to day responsibilities were and not limited to as follows: • Monitored parameters such as hardness, purity, COD, and BOD in water and effluent treatment plants • Well versed with pulp manufacturing processes like kraft and sulphite process. • Ensured that the filter, soft, and de-mineralized water was produced per the customer’s quality and production quantity requirements • Monitored the… Show more Chemical Engineer at Grasim Industries Ltd, Textile Division of the Aditya Birla Group. My day to day responsibilities were and not limited to as follows: • Monitored parameters such as hardness, purity, COD, and BOD in water and effluent treatment plants • Well versed with pulp manufacturing processes like kraft and sulphite process. • Ensured that the filter, soft, and de-mineralized water was produced per the customer’s quality and production quantity requirements • Monitored the outgoing effluent and adopting treatment procedures to ensure that the final effluent met the Government’s Pollution Control Board standards. • Understood and Learnt the usefulness of DCS(Delta V) in an Industrial setting. • Recovery of useful chemicals like Sodium Sulphate from the process. • Troubleshooting on the shop floor to ensure that quality and quantity aren’t compromised. • Involved in a setting with multiple unit operations like Evaporation, Crystallization, Drying and Filtration. • Used Six Sigma Concepts, Data Analysis and Statistical Process control tools to improve and maintain the process. • Involved in Downstream Recovery Operations in a pulp and fiber manufacturing setting like Crystallization, Filtration, Extraction and Drying. • Continuous Manufacturing of Biogas so as to Limit the usage of Furnace Oil in the Lime Kiln by 30%. Show less



Ruhr University Bochum

• Germany
• Research
• 700 & Above Employee

• Research Intern/Bachelor Thesis

  • Jan 2013 - May 2013

  Bochum Area, Germany Running Simulations to complement the experimental data obtained from experiments involving synthesis gas reactions with special emphasis on the F-T Process.



Titan Company Limited

• India
• Retail
• 700 & Above Employee

• Industrial Apprentice

  • Dec 2011 - Jan 2012

  Hosur An Inplant trainee at the biggest Jewellery Manufacturing company in the country. Understood the Casting and Moulding process that goes into the manufacture of gold. Understood the schematics of a manufacturing plant and the various processes both Upstream and Downstream including the Chemical Refining of Gold.



Ranbaxy

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Intern

  • Jun 2011 - Jul 2011

  Gurgaon Understanding the downstream processes involved in the manufacture of Pharmaceuticals. A 2 month Industrial Internship.