SUMMARY:

• Experienced as a Quality/Validation Engineer in FDA regulated Pharmaceutical environment with emphasis on Equipment Qualification.
• Proficiency in creating and reviewing Validation Protocols and Validation Summary Reports (VSRs).
• Expertise in developing Installation Qualifications (IQ), Operational Qualifications (OQ) and Performance qualification (PQ) for various manufacturing equipments and Analytical Instruments.
• Excellent understanding of aseptic environment requirements, working in sterile environment as well as cGMP compliance.
• Performed Temperature Mapping Studies using Kaye validator 2000 to document the thermodynamics of specific area.
• Developed FMEA and Fish bone Diagram for Risk Analysis to obtain quality product.
• Involved in writing deviation forms and resolving deviations.
• Performed Process Development Studies, CAPA and Root Cause Analysis to validate systems.
• Authored, reviewed and revised SOP’s for lab scale equipment as per cGMP requirements.
• Performed Gap analysis and wrote remediation plans.
• Utilizing FirstDOC (Documentum) in order to route Specification documents and validation documents for review and approval.
• Co­ordinate and performed internal audit to ensure compliance with GMP.
• Created and maintained project Quality plan, Quality policy and Quality audit report and ensured that no compliance issue is overlooked.
• Participated in quality planning meetings in which customer needs, requirements and expectations are reviewed as well as quality standard internal audits.
• Reviewed validation protocols and reports for equipment and instruments associated with manufacturing and laboratory areas, including and evaluation of deviations and conclusions derived from validation studies.
• Familiar with cGxP (cGCP, cGMP, cGLP), 21CFRPart 11, 21CFRPart 210, 211, 820 (medical device GMP) and associated FDA regulations.
• Excellent as a team player as well as independent worker as evidenced in the previous projects.
• Good communication skills, ability to adapt to a fast paced environment and a quick learner. Highly organized and good time management skills.

TECHNICAL SKILLS:

Validation: FDA Regulations, 21 CFR Part 11, VSR, VMP, cGMP, cGLP, cGDP, GAMP, SOPs, IQs, OQs, PQs

Operating Systems: Windows 95/98/2000/XP/Vista/7, Mac OS 9, Mac OS X

Equipment: HPLC, FTIR, TOC Analyzer, UV - VIS Spectrophotometer, Biomage system, Airborne and Liquid-borne Particle Counters, Microplate Readers, Autoclaves, Incubators, CIP Skids, Bioreactors, Freezers, Refrigerators, Incubators, Skids, Process tanks, Biomek 4000 Automated Workstation System

Other Tools/Software: MS Office, MS Visio, Kaye Validator 2000, SAP, Trackwise, Documentum (Docspace, FirstDOC), EFMS

PROFESSIONAL EXPERIENCE:

Confidential, West Point, PA

Validation Engineer

Responsibilities:

• Responsible for generation of Quality Assurance Plan (QAP), Requirements Specification/ configuration Specification (RSCS) and, Requirements Traceability Matrix (RTM) for Agilent 8453 UV-VIS Spectrophotometer.
• Utilizing FirstDOC (Documentum) in order to route Specification documents and validation documents for review and approval.
• Authored and executed Installation Testing/ User Acceptance Testing (ITAT) protocol of Agilent 8453 UV-VIS Spectrophotometer and wrote Quality Assurance Summary Report (QASR).
• Worked as an individual for the development of validation deliverables. Responsible for generation of Requirements Specification/ configuration Specification (RSCS), Requirements Traceability Matrix (RTM) for Biomek 4000 Laboratory Automated Workstation System with Biomek Software V4.0.
• Authored and executed IOQ protocol of Biomek 4000 Laboratory Automated Workstation System and wrote Quality Assurance Summary Report (QASR).
• Also involved in writing Administration and Operation SOPs for the Biomek 4000 instrument.

Confidential, Fridley, MN

Validation Engineer

Responsibilities:

• Contacted Supply Chain Quality Engineers (SCQE) and Suppliers to collect information about the methods used for manufacturing of Ascenda components (part of Infusion Products). The information collected is entered into the supplier information sheet (MFG31206) as per GDP regulations.
• Maintained tracking spreadsheet of SCQE and Supplier contact information in SharePoint.
• Monitored day to day activities, involved in status meetings for effective communication of the project situation.
• Assisted in writing process flow diagrams for Ascenda Components and Pump tubes, calculated surface area calculations for the parts having worst case scenarios and checked product as well as patient contact information.

Confidential, Malvern, PA

Validation Engineer

Responsibilities:

• Executed IOQ protocol and generated final report to upgrade the Shimadzu UV­2500 Series spectrophotometers with UVProbe version 2.34 software to UVProbe version 2.43 software. This upgrade involves a new computer and a change in the operating platform from windows XP to Windows 7.
• Involved in validating a previously qualified Bio image system with Intelligent Quantifier­11 software, upgraded to version 1.2.4.1 on a windows 7 Operating system, will be used for analysis and quantitation of IEF and SDS­PAGE gels used for release testing of Remicade FLP as well as to generate simple images from other analyses.
• Utilizing SAP and Docspace (EDMS) in order to route change controls and validation documents for review and approval.
• Accessed Electronic File Management System (EFMS) and Mc Laren Software to route the URS and DDS documents and to store purchase orders, P&ID Diagrams, Vendor IOQs and Equipment manuals.
• Wrote change controls for Shimadzu UV­2500 Series spectrophotometers and Bio image system and route the documents in SAP and Trackwise.
• Revising DDS/URS of analytical instruments like Shimadzu UV-VIS Spectrophotometer, Molecular Devices Plate Reader, TOC, cIEF, BioImager and FTIR for QC upgrade of ADMS7 to SDMS8 (generally used for backup archival).
• Involved in weekly tech support meetings to discuss about the updates of the current and future projects.

Confidential, Germantown, WI

Validation Engineer

Responsibilities:

• Responsible for generation of IQ and OQ protocols for Sapling SBP 3000 Series IP Clocks and Huber Unistat 912w Refrigerated/ Heating Circulator.
• Executed IQ and OQ Protocols and generated final report for Sapling SBP 3000 Series IP Clocks. The execution was performed to know the system software is properly documented, all devices connected to server network are correctly addressed and communicating, clock components are working normally and recovered satisfactorily from a utility loss or communication loss situation.
• Manage, author, review, approve and execute DQ, IQ/OQ/PQ, test scripts, summary reports for qualification and validation requalification activities.
• Provided support in the preparation of IQs/OQs/PQs protocols for manufacturing equipment such as Tanks, UV-VIS Spectrophotometers, Plate Readers, Autoclaves, Freezers, Refrigerators and Incubators in compliance with FDA regulations.
• Create and complete Change Control, Deviations, Investigations, SOPs and Impact Assessments.
• Used Kaye Validator to perform temperature mapping of controlled temperature units (Autoclaves, Incubator).
• Worked in collaboration with technical services, engineering, manufacturing and quality to improve the functionality of the equipment/process.

Confidential, Pennington, NJ

Commissioning/ Process Validation Specialist

Responsibilities:

• Worked as a team member of the Qualification Team, supporting the development and approval of validation deliverables and protocols. The project involves the Validation of large­scale process equipment used for the manufacturing of biopharmaceutical products. Equipment/ System types include Bioreactors, Autoclaves, Centrifuges, incubators, refrigerators, media prep vessels, media hold vessels, product hold vessels, Biowelders, Tubing welders and Temperature Control Units.
• Responsible for preparing, reviewing and executing IQ/OQ's for equipment Validation protocols.
• Assisted in development and approval of the equipment qualification Plan.
• Supported biotechnological process environment including writing IQ/OQ protocols, reports and assessments for a startup process facilities.
• Performed Document Review on executed Validation Protocols for GDP and Compliance.
• Ensure the compliance of the Qualification activities (protocol generations, executions, test documentation, summary report development and distribution of controlled documentations), with the Quality Policy and Standards, SOPs, cGMPs, GDP, GEP (Good Engineering Practices) and other requirements.
• Assisted in writing and executing IOQ for Clean HVAC System final fill and wrote validation summary reports for O2, N2, CO2, and Compressed gases.
• Performed Temperature mapping for ultra­low freezers, refrigerators and incubators using Kaye validator.
• Performed Temperature Hold studies (Heating/Cooling) for Media Hold Vessels, Media Prep Vessels and Product Hold Bins and recorded the data using Kaye Validator 2000 and SCADA system.
• Involved in writing and resolving deviations for Temperature Control Modules.
• Prepared Final Summary Validation Reports for the Change Control Implementation and closure.

Confidential, Rochester, MI

Validation/ QA Engineer

Responsibilities:

• Used Six sigma methodologies to perform DoE, Process Capability study, Statistical Process Control and Gage R & R, Gage Linearity and Bias, Process Mapping, Value Stream Mapping, Control Charts for optimization of various process parameters using Minitab 16.
• Successfully completed new product qualification, managed time lines for product qualification, product testing, analysis of test results (using MINITAB) and submission of reports.
• Evaluate and document risk assessments, DFMEA, PFMEA. Participate in the preparation of IQ, OQ, and PQ protocols and write summary reports. Perform test method validation (Gauge R&R studies- Minitab)
• Collect, analyze and interpret validationdata using statistical software to assess compliance with specifications and processcontrol.
• Performed Gap analysis and wrote remediation plans.
• Involved in developing Validation Master Plan, Equipment Validation Protocols, Cleaning/ Process Validation Protocols and Validation Summary Reports.
• Prepared and Executed SOP’s, Installation Qualification, Operational Qualification, Performance Qualification Protocols for lab scale equipment.
• Calibrated lab scale equipment (Mixer, Oven).
• Used Kaye Validator 2000 system to perform temperature mapping studies.
• Performed Temperature Distribution study of Convection Oven using Omega data logger.
• Developed FMEA (Oral Solid Dosage Forms especially Tablet Manufacturing) and Fish bone Diagram for Risk Analysis to obtain quality product.
• Reviewed and revised SOP’s for process equipment as per cGMP requirements.
• Performed Temperature Mapping Studies for Autoclave using Kaye Validator 2000 and wrote deviations for Autoclave.
• Co­ordinate and performed internal audit to ensure compliance with GMP
• Responsible for weekly project status updates to senior management/team members and with focus on milestone accomplishments challenges and status of project schedules.
• Maintained all documents using Electronic Document Management System (M­Files) in compliance with 21 CFR Part 11 Regulations.
• Involved in weekly co­ordination meetings to discuss about lab experiments.
• Supervised the quality system and effectiveness of the quality system is reported periodically to the Project Manager.
• Communicated between manufacturing and the customers, ensured that the product meets all specifications and customers satisfaction.
• Focused on corrective actions and preventive actions to avoid repetition (causes) and implemented solutions for continuous improvement.
• Created and maintained project Quality plan, Quality policy and Quality audit report and ensured that no compliance issue is overlooked.
• Reviewed validation protocols and reports for equipment and instruments associated with laboratory areas, including and evaluation of deviations and conclusions derived from validation studies.
• Participated in quality planning meetings in which customer needs, requirements and expectations are reviewed as well as quality standard internal audits.
• Developed Quality and Project Plans delineating scope of Systems Regulatory Compliance Services, applicable quality programs and SOPs, roles, responsibilities and deliverables.

Confidential, OH

Validation Engineer

Responsibilities:

• Generation and execution of validation protocols and generation of summary reports.
• Involved in commissioning, qualification and validation of laboratory and analytical equipment like HPLC, FTIR, TOC Analyzer, Airborne and Liquid-borne Particle Counters, Micro plate Readers, Plate washers and Spectrophotometers.
• Supported the revalidation and change control programs at pilot plant facility. Conducted Steam-in-place (SIP) studies on portable tanks and Autoclaves
• Perform Temperature Mapping/Biological Challenge studies on cGMP Autoclaves.
• Developed Standard Operating Procedures for laboratory equipment based on user requirement and functional requirement specifications.
• Responsible for preparing, reviewing and executing IQs/OQs/PQs protocols.
• Used Kaye Validator to perform temperature mapping of controlled temperature units (refrigerator, freezer, walk-in-freezer, autoclaves, incubator, walk-in-incubator and cryo freezer).
• Executed IOQ protocol for utilities like HVAC System
• Involved in writing the Standard Operating Procedures and precautions to be taken for safe/proper handling of analytical instruments like Ultraviolet-visible Spectroscopy, Atomic Absorption Spectroscopy, and Fourier Transform Infrared Spectroscopy and Utilities like WFI and HVAC Systems.
• Reviewed SOPs for the Installation Qualification of these instruments and also wrote summarized SOPs for the theory of operation as well as the working conditions for them. This was done to help a new operator understand the operations easily.
• Wrote and reviewed the system related SOPs to ensure compliance of company’s processes, policies, and procedures.
• Involved in documentation of different stages of validation life cycle in compliance with 21 CFR Part 11.