Validation Consultant

Summary

Diverse experience in Equipment Validation, Computer Systems Validation, Software Testing, Process Systems, and related documentation

Well versed with all stages of validation and testing, 21 CFR (Parts 11,210,211) Validation, Gap Analysis, Remediation Plan, SOP writing, and Qualification (IQ/OQ/PQ) Documentation.

Technical Summary

Experience in Equipment and computer systems validation in compliance with FDA standards. Experience in preparation of Validation Strategy, Process Engineering, Commissioning report, Kaye Validator operation, Validation Master Plan, Validation protocols (IQ OQ PQ) and Validation Summary Report. Experience in performing risk assessment, Validation and Gap Analysis.

Excellent understanding of unit operations including fermentation, cell culture and protein purification, Biochemical Processes, Validation approach to manufacturing processes and Cleaning Validation. Proficient in creating and maintaining Validation Matrix along with qualification documents, test documents, validation status reports and performing Gap Analysis. Knowledge of Corrective and Preventive Action (CAPA) reporting, handling and closing, using software systems like TrackWise.

Experience

Vertex Pharmaceuticals Inc Jul 2007 – Feb 2008

Validation Consultant-Contract Position

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. I am working as a validation representative for some software development/customization initiatives at Vertex.

• Developing the Validation Plans for Application/service development and manage the validation activities and documentation for the project initiatives

• Conducting risk assessment for the product/service from regulatory/business point of view and based the validation/testing on the level of risk

• Developed, executed and reviewed test plans, test scripts, change control requests, Validation protocols (IQ/OQ/PQ) and test summary reports for software validation

• Solely managed the validation activities for multiple products/services through effective use of available resources and brought them to completion

Biogen Idec Inc Jan 2007 – Jul 2007

Validation Consultant-Contract Position

Biogen Idec engages in the development, manufacture and commercialization of novel therapies primarily in the areas of oncology, neurology and immunology. I am working as a part of a validation documents review team for the QC Move to Bio 8 Project.

• Developing the Validation Production Plan executive summary reports for completed campaigns like Avonex, LTBeta, etc, to summarize the executed validation protocols, Change over protocols, cleaning validations and equipment-related protocols before and after the campaign

• Developed, executed and reviewed Equipment validation protocols (IQ/OQ/PQ) for freezers, incubators, Computer systems, Vapor Shippers, refrigerators, etc

• Working in tandem with quality engineering to review/correct executed protocols and then get them approved

• Used Kaye Validator 2000 for thermal mapping of equipment, during execution of qualification protocols and to generate qualification and calibration reports

Perkin Elmer Inc. Jun 2006 – Dec 2006

SQA/Validation Engineer-Contract Position

Perkin Elmer Inc is a leading provider of scientific instruments, consumables and services to the pharmaceutical, biomedical, environmental testing and general industrial markets. It is involved in design, manufacture, market and service of products and systems that require innovation, precision and reliability. I was solely responsible for the Quality Assurance and Validation analysis for two releases of ExacTag Analysis Software – a Sequence analysis tool, which uses raw peak data from LC-MS/MS analysis to identify and quantify protein mixtures

• Involved in the preparation of User/Functional Requirements for ExacTag Analysis Software

• Involved in developing all the testing deliverables like Test Plan, Test Cases, Requirements Traceability matrix, Test Summary Report, etc and a testing strategy based on different project variables like time, new features added, state transitions, etc

• Created test cases for both manual testing and automated testing.

• Involved in assessing future 21 CFR part 11 requirements for the product and made recommendations accordingly

• Conducted Installation testing, System Testing, Backend testing, Regression testing and Acceptance testing for the product

• Used Lotus Notes based P.S. Bugs 2.0 software for bug tracking and reporting.

Merck & Co., Inc., PA Nov 2005 – Apr 2006

QA/Validation Analyst-Contract Position

Merck & Co., Inc., a pharmaceutical company, engages in the discovery, development, manufacture, and marketing of various products for human and animal health. Merck is the world's top pharmaceutical and Research Company. As an Analyst, I was responsible for the Quality Assurance and Testing Processes for Master Data Management for Market Definition and Product. I was also involved in a related sister project – Master Data Management for Alignment Data

• Reviewed the User/Functional Requirements to prepare a testing strategy and approach

• Involved in creation/review/approval of the following documents – Test Plan, Test Specification, Installation Qualification, Test Cases, Requirement Traceability Matrix, Quality Assurance Plan, QA Summary Report, Test Summary Report

• Followed Merck SLC and Merck Corporate Policies, during creation of the documents related to testing and used Documentum as the document management system

• Reported and Managed the Defects through Rational ClearQuest

• Conducted System Testing, Integration Testing, Installation Testing, Ad-hoc testing and Performance testing

• Conducted backend testing and data reliability testing using SQL Navigator

• Reviewed the Sarbanes-Oxley Act and verified the conformance of the product and testing activity to this policy through scripted test cases.

Millipore Corporation, MA May 2005 – Sep 2005

Lab Process Engineer I

Millipore Corporation provides products and services for biopharmaceutical manufacturing, clinical, analytical, and research laboratories worldwide. Its major products consist of process filtration and chromatography products that serve to separate viruses or other biological contaminants from biologics or other fluids; and process monitoring tools. I was involved in the project to analyze and trouble-shoot the air integrity failure of Pellicon 2 Maxi cassettes in Amgen’s Enbrel process.

• Involved in setting up an in-house bench top pilot-scale purification system replicating the actual Enbrel Process

• Wrote documentation for Validation life cycle, in accordance with FDA regulations including: Validation plan and Protocol, Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).

• Assisted in design of experiments for the projects, developed and executed SOP’s for TFF process in a BL-2 facility

• Performed Statistical Analysis of the results data from in-house runs, calculated various controlling

parameters and through failure analysis found the root cause of Air Integrity failure and made recommendations for change in the Enbrel Process, without any change in yield of the purification process

• Evaluated TFF devices with various designs and different membranes for process performance, optimization and consistency studies

• Implemented and executed IQ, OQ and PQ documents for chromatography systems, autoclaves, incubators, freezers and various analytical instruments

Millipore Corporation, MA Oct 2003 – Nov 2004

Lab Process Engineer I -Contract Position

Millipore develops, manufactures and markets several thousand products ranging from pipette tips to multi-million dollar custom-engineered manufacturing systems. The majority of the product line is based on microporous membrane, ultrafiltration, and chromatographic technologies.

• Evaluated TFF devices and related purification processes with various designs and different membranes for process performance, optimization and consistency studies.

• Assisted in design of experiments for various projects, develop and execute SOP’s for new TFF products in a BL-2 facility, and perform statistical data analysis.

• Gathered/ Analyzed data to study model behavior of UF devices & calculate controlling parameters

• Managed Lab inventory, scheduled Calibration and Validation activities, Implemented and executed IQ, OQ and PQ for chromatographs, autoclaves, Data Acquisition systems, Digital Thermometers, Control Chambers and various analytical instruments

• Prepared test protocols, conducted design of experiments, and assembled bench-top pilot scale

Systems for Pellicon-3 UF Cassettes characterization and scalability studies

• Successfully completed the following projects:

o Development of Pellicon 2 Micro device through the testing of various prototypes with different design parameters for protein flux and permeability and compare them with those of Pellicon 2 Mini device to evaluate scalability

o Effects Study of Pellicon 2 Micro to evaluate the consistency of device performance when subjected to different stress conditions like high temperature, pressure, alkali exposure, solvent exposure, freeze storage with or without storage agents, time of storage, etc.

Massachusetts Bioprocess Development Center, MA Jun 2002- Oct 2003

Research Assistant

The Center at UMass Lowell is an interdisciplinary research and development and education center that assists start-up biotechnology companies in the development of procedures that can become validated, cGMP compliant, manufacturing processes

• Worked as part of a four- member team conducting research for corporate partners in accordance with cGLP protocol.

• Worked on research-scale upstream equipment conducting microbial fermentations and downstream purification systems like BIOCAD.

• Performed gel electrophoresis, protein assays, chromatography (preparatory LC and HPLC).

• Successfully completed the following projects

o Development and optimization of an automated exponential feed system, based on AFS BioCommand software and control programming using the exponential growth equation for production of proteins by Escherichia Coli fermentation

o Development of purification protocol using E.Coli cell lysate containing Shigatoxin-B using the

BIOCAD chromatography system, after trials with different resins, pH and strategies

Education

University of Massachusetts Lowell, MA, USA Aug 2001 - Oct 2003

M.S. Chemical Engineering

University College of Technology, AP, INDIA Dec 1997 - Apr 2001

B.S. Chemical Engineering

Certifications/Training

Graduate Certificate in Bioprocessing and Biotechnology

Diploma in Software Quality Assurance

Technical Skills

Testing Tools: WinRunner, QTP, Kaye Validator

Bug/CAPA Tracking: Test Director/Quality Center, Clear Quest, TrackWise

Programming languages: C, C++

Others: Documentum, MSOffice, Matlab, Qdoccs, Vdoccs, SOPVault,

and Lotus Notes

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