Engineer Project

Mathew

**********************@*****.***

Summary

•8 years of working experience as a Quality Analyst and Validation Engineer with exceptional communication, analytical, creative and management skills to help provide cost effective and customer-centric IT solutions and services.

•Extensive experience working with biotechnology and biopharmaceutical industries.

•Validation Deliverables: Validation Master Plan, Summary Report, Test plan, URS, FRS, DS, RTM, DQ, IQ, OQ, PQ protocols in compliance and conformance with FDA, MHRA Regulations.

•Experienced in gathering user requirements, analyzing and preparing project deliverables such as Project Charter, Communications Matrix, Business Requirement Document (BRD) and Functional Specification Document (FSD).

•Working experience with ensuring compliance to Part 11, 820, GAMP and ICH guidelines.

•Extensive experience in User Interface (UI) designs, content management and working with wireframes.

•Experience with Content Management system such and Document Management System.Experience in Developing and Executing Test Plans, Test Procedures, Test Scripts, Test Cases, Test requirements and testing standards.

•Experience in Design failure mode effect Analysis (DFMEA) and Process failure mode effect analysis (PFMEA).

•Performed various types of testing like Black box, UAT and Performance testing.

•Skilled at conducting Joint Application Development (JAD) sessions with stakeholders, project meetings, reviews and walkthroughs.

•Provided training and Assisted new users On-Boarding of the environment to facilitate UAT (User acceptance Testing).

•Experienced in managing schedules, deadlines and resources using MS Project taking into account the Triple Constraint and creating Work Breakdown Structure (WBS) and MS PowerPoint presentations for management review.

•Experience in assisting QA team with preparation of test plans and test cases from Use cases.

•Possess hands-on knowledge of different methodologies such as Waterfall, Agile and RUP to deliver projects on time within budget with ever changing requirements.

TECHNICALSKILLS:

Validation skills

21CFR part 11, cGMP, cGLP, cGCP, Cleaning validation, Process and equipment validation, CIP,SIP and 21CFR part 820

Analytical Software

LIMS, AERS, SAS-JMP

Laboratory Equipment

HPLC, GC, FTIR, UV-Vis spectrophotometer, Tablet Punching Machine, Franz cell diffusion apparatus, Capsule Filling Machine

Testing and Tracking Tools

Quick Test Professional, Load Runner, Quality Center

Databases

Oracle, MS-SQL Server, MS Access

Clinical Applications

CABS, SQL *QA, SQL *Stability, LIMS, Oracle Clinical 4.0, Clinical trials, PLC

Operating System

Windows OS, Vista

Projects Summary:

Mylan Pharmaceuticals, PA

Role: Validation Engineer July 2013 Till Date

The project involved implementing two brand new systems Labware LIMS and trackwise systems. I worked on Validation of the two systems.

Responsibilities:

•Analyzed the Business requirements and assisted in preparing the Validation Master Plan.

•Involved in project scheduling, tracking, and resource allocation in regards to Performance Qualifications for Equipment, Utility, Facility, Cleaning, process, and Computer Validation studies.

•Worked on Infrastructure Qualification for Bartender Application (Barcode and Labeling software) and interacted with Information services (IS) for compliance of the networks and associated infrastructure and their operations

•Reviewed and developed validation deliverables- master plan/Summary Report, URS, FRS, Requirement traceability matrix (RTM), IQ, OQ and PQ protocols

•Vertically integrated GXP Systems in (R&D, manufacturing and distribution) and apply such controls and compliance measures.

•Work with laboratory information system vendors with ASTM specifications..

•Develop test procedures/test cases and test tools.Developed and executed IQ, OQ, PQ protocols and test cases stored in the Test Plan and reported deviations using HP Quality Center.

•Performed the comprehensive design FMEA (DFMEA) and the process FMEA (PFMEA) for the product and the process risk assessments. Performed the end-user risk assessments for developing the Instruction for Use (IFU).

•Responsible for inspecting applications in the regulated pharmaceutical sector in accoradance with GXP systems

•Ensured that all documentation is FDA and GMP compliant.

•Experience in preparing Deviation Reports when the test criteria did not meet the acceptance criteria.

•Provided CR overdue reports on a daily basis using Trackwise tool(TW).

•Updated the FMP database on a daily basis and assigned SVP and volume numbers based on customer request.

•Involved in developing Requirements Document, Technical Specifications and the Installation Plan for Upgrade of Documentum 6.0 to Documentum 6.7SP1.

•Provided training and tutorials to customers in running Trackwise (TW) reports.

•Responsible for retrieving, archiving and maintaining SVP documentation (URS, arch diagrams, CR docs)

Environment: Trackwise, Labware LIMS, Livelink, FileNet, FileMaker Pro Oracle 9i

Planets Pharma, CHICAGO, IL Nov 2012 to Jun 2013

Validation Analyst

Project Overview: Computer System validation of IBM SCORE (Solution for Compliance in a Regulated Environment), which is an Enterprise Document Management System (EDMS) and Track Wise v 8.0 Quality Management System (QMS).

Responsibilities:

•Directed the clinical trial data capture and worldwide data collection systems for various therapeutic areas.

•Performed the business requirements gathering by questioners, Interview business area experts, surveys and JAD sessions.

•Experience throughout software lifecycle for medical devices following FDA guidelines.

•Developed Technical specification, Use cases, data model etc.

•Reviewed and approved Process Validation Protocols from the manufacturers to ensure that the process meets FDA requirements, complies with cGMP's and company policies and procedures.

•Define appropriate project plans and schedules.

•Assisted in on-going process improvement efforts to ensure Test Planning, Execution, and Reporting is effective, efficient, standardized, coordinated, and integrated.

•Was responsible for indexing of the tables in that data warehouse.

•Submit and maintain defect reports using PVCS – Tracker defect tracking system.

•Coordinated with other organizations to obtain an automated monthly data feed, from an external system, which in turn is used to update TrackWise.

• Applying the fixes that are required to Install Empower Interface.

•Installing Empower Interface module.

•Production support after implementing the Empower Interface

•Worked closely with Business Owners and Stakeholders to outline Business Requirements.

•Hands on experience in pharmaceutical device verification and validation.

•Designed conceptual and logical data models of Data Warehouse and tables.

•Identified gaps and performed gap analysis with respect to CMS requirements

•Created Mapping Documents, Report Mockups and modified existing report mockups as to CMS requirements and finalized for development

•Wrote PL/SQL statement and stored procedures in Oracle for extracting as well as writing data.

•Performed analysis on enterprise data/report integration & provided functional specification to development team to build Enterprise Reporting Systems.

•Reviewed requirements and understand technical recommendations and constraints, and develop comprehensive and accurate functional specifications; Data Mapping, and process flows.

•Developed new and debugging existing, Plant (Mathematical) and Behavioral Matlab/ Simulink Model for Traction Motor, Alternator and Inverter, based on the requirement of requisition of locomotives.

•Adapt Matlab/Simulink subsystem plant and control models for real-time execution in HIL system.

Environment: Windows XP, Business Objects, Zachman Framework, MS Excel, Word, Casewise Corporate Modeller, Process Modeling, power point, SQL, PL/SQl, DB2, SAS database

CATALENT PHARMA SOLUTIONS,WINCHESTER Jan 2011 to Oct 12

Validation Engineer

Project Overview: This project involved validating computer software application and analytical laboratory equipment in compliance with regulations and validating the operating procedures. LIMS was used for maintaining laboratory records.

Responsibilities:

•Conducted GAP Analysis to identify variances in desired business process and Teradata DCM functionality

•Created diagrams in the SLM process at top levels as well as low levels.

•Analyzed and designed the requirements for a new system based on the Agile methodology.

•Organized Joint Application Developments (JAD) with end-user/clients/stake holders and the IT group to gather requirements.

•Extensive experience working as a Validation engineer for FDA regulated, mission critical GXP Pharmaceutical Systems in the Global Solution delivery model (Offshore- Onshore).

•Involved in managing Mobile deployments while also ensuring security policies are enforced.

•Compatibility testing, Retesting, Regression Testing, Performance testing, Load testing and stress testing in mobile handsets and web based applications.

•Configured SAP CRM products per requirements, including testing, problem solving, and debugging.

•Use of mobile database and way of synchronization.

•Experience in testing the application on different Mobile Handset.

•Integration with Java Message Services expanding options for integrating enterprise systems with mobile database application.

Environment: SQL, MS Visio, JAVA, MS Project, TOAD Manager, Quick Test Pro, Bugzilla, Oracle, Teradata, SFA

BECTON DICKINSON, Franklin Lakes,NJ Mar 2009-Dec 2010

Validation Engineer - Medical Device

Responsibilities:

•Written and executed Change Verification Protocols for the medical device

•Written test cases and test scripts

•Troubleshoots problems on equipment/process/product, using DOE, FMEA, cause and effects relationships and other techniques

•Prepared Automation test scripts for Integration test

•Performed CAPA testing for the medical device

•Used a defect tracking system to document and track software bugs

•Worked with the Software Developers to solve the software bugs and verify changes

•Involved in the Software Development for the medical device

GE Healthcare, Bangalore, India June2006-Feb 2009

Technical support lead-Medical device

Responsibilities:

•Install Maintain, Calibrate, Inspect and Repair medical equipment and instrumentation.

•Provide Pre Installation support and coordination to end users

•Perform preventive maintenance and electrical safety testing of clinical equipment, devices and systems.

•Maintain documentation on equipment, inspections, and equipment repairs and failures.

•Provide technical assistance and instruction to personnel regarding equipment operation and maintenance.

Education:

Bachelors in Pharmacy, Dr. MGR University, India

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