Experience

PureTech Health
• United States
• Biotechnology
• 1 - 100 Employee
• Sr. CSV Engineer Lead/Manager

  • Mar 2022 - Present

Rubius Therapeutics
• United States
• Biotechnology Research
• 1 - 100 Employee
• Sr. CSV Lead/Manager

  • Feb 2022 - Oct 2022


Sage Therapeutics

• United States
• Biotechnology Research
• 400 - 500 Employee

• Sr. CSV Engineer Lead

  • Aug 2017 - Jan 2022

  Sage is a therapeutic company that is committed to discovering, developing and delivering novel medicines to transform the lives of patients with life-altering disorders of the central nervous system (CNS). The company implemented a Veeva systems like Vault Clinical (eTMF and CTMS), Quality Documents Vault (QDMS) and Regulatory Vault (RIMS) systems, FTS platform is a Linux based sFTP server by Validated Cloud, ACUTA Regulatory Information Management (ARIM), ComplianceWire Electronic Learning Management System (eLMS), Elluminate by eClinical solutions, and Argus Safety for Adverse Events, TrackWise for logging Product complaints. I was involved in leading and overseeing the CSV needs for all the systems being implemented and getting ready for FDA inspection. I was also involved in creating all CSV deliverables starting from Validation Plan to Validation Summary Report including System/User Acceptance Test Scripts, Data Migration Test Scripts, RTM, discrepancy reports for logging issues and re-validation of systems. Show less



Vertex Pharmaceuticals

• United States
• Biotechnology Research
• 700 & Above Employee

• CSV Engineer

  • Sep 2012 - Jul 2017

  Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative new medicines so people with serious diseases can lead better lives. The company implemented a customized Information Request Management System (IRMS) from OBA for handling patient/customer requests on drugs, Argus Safety for logging Adverse Events, TrackWise for logging Product complaints and CAPA workflows, and Oracle EBS and Revitas iMANY for financial transactions and payments, and ETL Processes using TalenD. I was involved in creating System Test Scripts, User Acceptance Test Scripts, Data Migration Test Scripts, Installation Configuration Test Scripts, System Test Plan, RTM, validating the applications and ensuring compliance with FDA regulations, Validation and production implementation of IRMS, TrackWise and Argus applications, Creation of Workflows for initial release and updates of the system deliverables, and discrepancy reports for logging issues and re-validation of systems. Evaluated, Incorporated and Tested SOX Compliance requirements in Oracle EBS and Revitas iMANY systems, and integration of these systems with each other and ETL processes between these systems using TalenD data integration tool. Show less



Stryker

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• System/Software Verification & Validation (V&V) Engineer

  • Feb 2012 - Aug 2012

  I worked as Validation Lead, managed the system validations from start to finish following current FDA 21 CFR Part 11 requirements. Responsible for and involved in complete validation of the Extrusion line from creating, managing, and maintaining the documents required by this procedure for the development and validation of the proposed systems such as Validation/Test Plans, URS, FS, IQ/OQ, RTM, Validation report after completion of validation/execution, MVR and ensure compliance with FDA regulations. Also responsible for assigning and maintaining resources for the protocol executions, systems validation and Lead the project from the front end. Show less



Boston Scientific Corp.

• System/Software V & V Engineer

  • Apr 2007 - Feb 2012

  I was involved in multiple projects like Validating Machine Console Application which interacts with the MS SQL database and generates reports using Reporting Service, validating SQL stored procedures for various reporting applications, Creating Protocols, Validation/Test Plans and validating PLC software installed in the systems/equipments and ensure compliance with FDA regulations, Creation of URS, FS, IQP, OQP, PQ and RTM for validation of Maintenance, Material Management, PLC, Compliance and Engineering software applications, LIMS, Clinical Trail Management System (CTMS) and systems/equipments, Creating change requests for changing systems and discrepancy reports for re-validation of systems. Created automated test scripts using QTP for testing of internal reporting applications developed in MS .Net and created QTP scripts to seed test data into the database. Assigned and maintained resources for the systems validation and Lead the project from the front end. Show less

• QA Analyst/Software Validation

  • Jul 2006 - Mar 2007

  Guidant/Boston Scientific developed a web-based software applications called Clinical Trail Management System (CTMS) and Clinical Document Control (CDC). The purpose of these applications is to collect and manage Clinical Research data. The project involves customizing application to replace an existing legacy system and migrating all the data from legacy systems to the new applications. One of the primary requirements of the system was to maintain documents and ensure compliance with FDA regulations and integration between the applications for data flow. Independent Java tools with GUI’s were implemented to allow business users to specify object attributes and to import thousands of existing documents from a file share into the Content application. Ascent Capture 6.0 (Kofax) is used for scanning regulatory documents of clinical studies with assigning attributes and importing into Clinical Document Control (CDC). Show less