Pritash Patel, Pe Email & Phone Number

Raleigh, Nc, Us

Raleigh, North Carolina, United States

Takeda (Los Angeles, CA) – Automation Engineering Support and Computer System Validation (Nov 2024 - Present)- Worked with Production Engineers to understand process requirements for all manufacturing areas and designed solutions in the Siemens XFP Manufacturing Execution System (MES) platform to capture those requirements. - Configured MES to read and write the appropriate information to allow effective communication with the Emerson DeltaV DCS platform which runs in parallel with MES. - Used and developed generic functions in MES that incorporated logic that could be used across multiple production areas. - Designed MES to be user friendly while also providing appropriate checks and signatures to record and ensure that the correct action is performed by the operators on the floor.

Raleigh, North Carolina, United States

Takeda (Social Circle, GA and Los Angeles, CA) – Automation Engineering Support and Computer System Validation (Jan 2023 - Nov 2024)- Worked with Production Engineers to understand process requirements for all manufacturing areas and designed solutions in the Siemens XFP Manufacturing Execution System (MES) platform to capture those requirements. - Authored functional specifications to satisfy requests from Process Engineering, Quality, and Validation. - Configured MES to read and write the appropriate information to allow effective communication with the Emerson DeltaV DCS platform which runs in parallel with MES. - Used and developed generic functions in MES that incorporated logic that could be used across multiple production areas. - Designed MES to be user friendly while also providing appropriate checks and signatures to record and ensure that the correct action is performed by the operators on the floor.- Developed and executed Installation and Operational Qualification (IOQ) and Operation Qualification (OQ) protocols for the Siemens XFP Manufacturing Execution System (MES) platform to validate automation change controls.- Developed and executed IOQ protocols for the Emerson DeltaV DCS platform to validate automation change controls.- Compiled validation protocol results in final reports to provide assurance that the automated control system is compliant with FDA requirements.

Raleigh, North Carolina, United States

Takeda (Social Circle, GA) – Automation Engineering Support (Sep 2022 - Jan 2023)- Worked with Production Engineers to understand process requirements for all manufacturing areas and designed solutions in the Siemens XFP Manufacturing Execution System (MES) platform to capture those requirements. - Authored functional specifications to satisfy requests from Process Engineering, Quality, and Validation. - Configured MES to read and write the appropriate information to allow effective communication with the Emerson DeltaV DCS platform which runs in parallel with MES. - Used and developed generic functions in MES that incorporated logic that could be used across multiple production areas. - Designed MES to be user friendly while also providing appropriate checks and signatures to record and ensure that the correct action is performed by the operators on the floor.

Greater Boston

Thermo Fisher Scientific (Plainville, MA) - Commissioning, Qualification, and Validation (Feb 2022 - Sep 2022)- Led the validation activities for the deployment of the Rockwell Automation FactoryTalk PharmaSuite Manufacturing Execution System (MES) platform which included creating and executing Installation Qualification (IQ) and Performance Qualification (PQ) protocols. - Authored and executed an Installation and Operational Qualification (IOQ) protocol for the Cytiva Unicorn System.- Executed an IOQ protocol for the Rockwell FactoryTalk AssetCentre System.- Summarized protocol execution results into individual reports to provide assurance that the system was installed, configured, and fully functional.

Greater Boston

Arranta Bio (Watertown, MA) – Commissioning, Qualification, and Validation (Jun 2021 - Jan 2022)- Developed the User Requirement Specification (URS) for various systems which identified the requirements that must be met for the systems to be suitable for their intended purposes. - Authored commissioning, Installation and Operational Qualification (IOQ), and verification testing documentation. - Conducted commissioning, qualification, and verification testing to ensure systems met established design requirements and end-user quality expectations. - Established cycle parameters at each stage of the sterilization process resulting in efficient and effective autoclave liquid load cycles.- Generated performance qualification (PQ) testing documentation for the autoclave liquid load cycles.- Performed PQ testing for the autoclave liquid load cycles to demonstrate that the system performed as expected and met all requirements for 6-log reduction of liquid loads.- Created reports to summarize findings and further ensure that acceptance criteria were met and the systems were fit for their intended uses.

Raleigh, North Carolina, United States

Takeda (Social Circle, GA) – Computer System Validation (Aug 2020 - May 2021)- Developed and executed Installation and Operational Qualification (IOQ) and Operation Qualification (OQ) protocols for the Siemens XFP Manufacturing Execution System (MES) platform to validate automation change controls.- Developed and executed IOQ protocols for the Emerson DeltaV DCS platform to validate automation change controls.- Compiled validation protocol results in final reports to provide assurance that the automated control system is compliant with FDA requirements.Takeda (Social Circle, GA) – Automation Engineering Support (Jan 2020 - Aug 2020)- Worked with Production Engineers to understand process requirements for all manufacturing areas and designed solutions in the Siemens XFP Manufacturing Execution System (MES) platform to capture those requirements. - Authored functional specifications to satisfy requests from Process Engineering, Quality, and Validation. - Configured MES to read and write the appropriate information to allow effective communication with the Emerson DeltaV DCS platform which runs in parallel with MES. - Used and developed generic functions in MES that incorporated logic that could be used across multiple production areas. - Designed MES to be user friendly while also providing appropriate checks and signatures to record and ensure that the correct action is performed by the operators on the floor.

Raleigh, North Carolina, United States

Takeda (Social Circle, GA) – Automation Engineering Support (Apr 2019 - Dec 2019)- Worked with Production Engineers to understand process requirements for all manufacturing areas and designed solutions in the Siemens XFP Manufacturing Execution System (MES) platform to capture those requirements. - Authored functional specifications to satisfy requests from Process Engineering, Quality, and Validation. - Configured MES to read and write the appropriate information to allow effective communication with the Emerson DeltaV DCS platform which runs in parallel with MES. - Used and developed generic functions in MES that incorporated logic that could be used across multiple production areas. - Designed MES to be user friendly while also providing appropriate checks and signatures to record and ensure that the correct action is performed by the operators on the floor.Alnylam (Boston, MA) – Automation Engineering Support (Feb 2019 - Apr 2019) - Developed protocols per the Automation Commissioning and Qualification Plan for a new manufacturing facility to verify software functions as defined in the Functional Requirement Specifications.

Morrisville, North Carolina, United States

- Conducted hydraulic and pneumatic calculations using simulation software for various projects.- Assisted in the development of piping and instrumentation diagrams.

Raleigh, North Carolina, United States

- Enhanced convective sedimentation assembly methods with an end goal of engineering a cellular artificial leaf capable of harvesting solar energy. - Determined the optimal method to fabricate and incorporate microfluidic channels for this specific application in the structure.- Presented research at the 15th Annual Summer Undergraduate Research Symposium at North Carolina State University.

Aurora, North Carolina, United States

- Collaborated with Project Engineers and their teams to facilitate the commissioning of a pilot plant.- Organized and reviewed process stream information documents to assist Project Engineers in their review of mass and energy balances for the design of a new hydrogen fluoride plant.

Raleigh, North Carolina, United States

- Tutored 2-3 students individually over the course of a semester in either Organic Chemistry I or Calculus I.- Held biweekly sessions with each student to assist in their understanding of the material.- Encouraged the development of independent study skills.

Aurora, North Carolina, United States

- Process Engineer Intern for the Superphosphoric Acid and Fertilizer Department of PotashCorp.- Identified and implemented projects that increased efficiency and lowered costs throughout the plant. - Updated piping and instrumentation diagrams.- Conducted numerous experiments on monoammonium phosphate and diammonium phosphate to determine size distribution, uniformity, and solubility.- Generated a system to track plant efficiency which assisted Production Engineers and Plant Operators.- Modified process safety management guidelines.- Compiled daily reports that summarized production and highlighted efficiency in the area.

Raleigh, North Carolina, United States

- Tutored 2-3 students individually over the course of a semester in Calculus I.- Held biweekly sessions with each individual student to assist in their understanding of the material.- Encouraged the development of independent study skills.