Project Engineer

Imad Mohammed

EMAIL: ************@*****.***

CELL: 469-***-****

PROFESSIONAL SUMMARY:

Diverse experience in Pharmaceutical/Medical Device industries with emphasis on, medical device validation, computer system validation, software testing, testing system and equipment validation.

Strong knowledge and background of Software Development Life Cycle (SDLC), especially Agile and V-model.

Strong understanding of 21 CFR part 11 drug GxP requirements including electronic records, electronic signatures, system validation strategies, Documentation and Quality System Regulation (QSR).

Expertise in preparing protocols for various stages in Computer Systems Validation (CSV): Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)

Expertise in developing and reviewing Validation Master Plan (VMP), Business/User Requirement Specifications (BRS/URS), Design Specifications (DS), Functional Requirement Specifications (FRS), Validation Summary Reports (VSR) and Requirement Traceability Matrix (RTM).

Strong knowledge about Pharmaceutical/Medical device regulations like FDA: 21 CFR Part 11, 21 CFR Part 58, 21 CFR Part 210, 21 CFR Part 211 and 21 CFR Part 820,ISO 13485,ISO 7206, ISO 14971

Knowledge and experience in working with GxP (cGMP, GDP, GCP, GLP) suites and SOPs.

Good knowledge and experience in using systems like Documentum, TrackWise, AERS and Argus

Proficient in Calibration and Validation of analytical & laboratory instruments like Mass Spectrometer, Chromatography (GC & HPLC), Autoclaves, Thermocouples, Incubators, Reactors using Labware LIMS.

Good experience in GUI, Backend, Integration, Regression, System, Black box performance and Functionality Testing

Experience in performing Gap Analysis, reviewing and performing Corrective and Preventive Action (CAPA) and suggesting Remediation Plan to mitigate non-compliance.

Solid analytical skills and ability to do root cause analysis of situations with an in-depth evaluation of various factors

Well aware of FDA’s regulation of medical devices, pre-market notifications (510k), 21 CFR Part 820 (Medical Device Quality System Regulations), FDA Regulatory Submissions

Ability to work independently and as a part of a multi-disciplinary team in fast paced environment, possess solid researching skills.

Analytical thinking, problem solving skills and positive attitude.

TECHNICAL SKILLS:

Applications

LIMS, Documentum, AERS, Argus, Track wise,OATS

Validation

21 CFR 11(210,211 & 820), cGxP (cGMP, cGDP, cGLP, GAMP), RTM, Summary Reports, Audit trails.

SDLC

Waterfall and Agile Models.

Operating Systems

Windows, Mac, LINUX and UNIX

Databases

Oracle, SAP, My SQL, SQL Server, MS Access.

Web Technologies

VB Script, XML, HTML, Java Script.

Business tools

MS Office, MS Projects, MS Outlook, MS Visio, Photoshop, Acrobat.

Tools

Minitab, Vision, Aspen plus, Hysys,MATLAB, ChemCAD.

PROJECT DETAILS:

Illumina Inc., Hayward, CA Feb 2016 - Current Validation Analyst

Illumina, Inc. is an American company that develops, manufactures and markets integrated systems for the analysis of genetic variation and biological function. Using its technologies, the company provides a line of products and services that serve the sequencing, gentyping and gene expression markets.

Project: As a member of the team the objective was to validate the MiSeq Equipment and the Optical Alignments Test software(OATS) the software used in the MiSeq Equipment and gathering requirements, identifying best practices, and testing/validating the functionality.

Responsibilities

Validated the Optical alignment test software (OATS) and MiSeq equipment in compliance with FDA regulations.

Involved in the preparation of Validation Master Plan (VMP)

Assessed 21 CFR Part 11 requirements and analyzed the organization’s current validation state

Devised the User Requirement Specification (URS) for MiSeq equipment and Optical alignment test software (OATS) and test method like Optical Test Target (OTT) Screening.

Spreadsheet Design, Verification and Validation for OTT Screening on the OAT Software.

Involved in developing Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) for OATS and its test method like Optical Test Target (OTT) Screening.

Developed Test cases, Test Scenarios and Test Data according to Development Specifications using Test Director.

Conducted IOQ and documented the test results, deviations and corrective actions.

Conducted Functionality testing and Interface testing during the Operational Qualification (OQ).

Involved in the preparation of Validation summary report (VSR) to summarize all the documentation and instrument validation activities.

Involved in assessment of risk involved with other systems and documented in Risk Assessment Document.

Developed Requirements Traceability Matrix (RTM) to keep track of the changing requirements

Worked on a parallel project involving Data Migration

Developed and executed validation guidelines for cGLP practices

Cordis Corporation, Miami Lakes, FL Aug 2015-Jan 2016

Validation Engineer

Cordis Corporation develops and manufactures diagnostic and interventional products to treat patients who suffer from coronary and peripheral vascular diseases.

Project: The project involved the equipment validation of Autoclaves, TOC Analyzers by GE Sievers, UV-Vis Spectrophotometer from Agilent, HPLC and GC with Chemstation Software from Agilent, Chromatographic method validation and process validation of small volume parenterals, which employed a distributed control system. The project also involved interfacing lab instruments with the Labware LIMS.

Responsibilities

Involved in the calibration of HPLC and GC, and checked its accuracy, detection limits, noise level, precision, reproducibility, repeatability and robustness.

Developed and executed IQ, OQ and PQ protocols, prepared the VSR to summarize all the documentation and instrument validation activities.

Created templates for method validation protocol, method validation report, standard test method.

Gathered URS and FRS for the Chemstation Software and its integration with LabWare LIMS.

Prepared documents for Test cases for Integration, Functional Testing and User Acceptance Testing (UAT) using Quality Center tool.

Reviewed and drafted Standard Operating Procedures (SOPs) and User Manuals for the equipment and associated software to ensure they meet FDA requirements.

Maintained Requirement Traceability Matrix (RTM) to track requirements.

Assisted in initiating and conducting Gap Analysis and Remediation Plan for lab equipment and software interfaced with LIMS for 21 CFR Part 11 compliance and prepared Deviation Reports.

Reviewed and carried out UAT, Positive testing, Negative testing, Regression testing for the Chemstation software.

Also performed non- functional testing like Performance Testing, Stress Testing, and Documentation Testing for the software.

Involved in the validation of equipment and software associated with the Process Validation for manufacture of small volume Parenterals and automated filling.

Prepared specification documents for Labstation module of LIMS and created test scripts for positive, negative, regression and the validation of Labstation module for interfacing lab instruments with LIMS Lab Ware.

Monitored the dry runs for the labstation module and changed test scripts accordingly for the events generated.

Novavax Inc, Gaithersburg, MD Oct 2014 – July2015

Validation Engineer/Technical Writer

Novavax Inc, is a clinical-stage biopharmaceutical company committed to delivering novel products to prevent a broad range of infectious diseases

Project 1: The project involved writing the scripts for validation of ARGUS Safety, the Adverse Event reporting System (AERS).

Project 2: This project involved managing official project documentation generated by the company, to be stored in the Document Management System, and managing the workflow of documents, it also involves maintenance of EMC Documentum based custom applications pertaining to the manufacturing, medical affairs and record management domains.

Responsibilities:

Assessed the company’s current validation status preceding an internal audit, reviewed pre and post market summary reports to ensure compliance with FDA regulations.

Was involved in validation of ARGUS Safety by creating a Validation Master Plan in accordance with FDA regulations, particularly 21 CFR Part 11, GLP and GMP.

Involved in ensuring all compliant pre and post marketing safety reports, writing test specifications, testing methodologies and user manuals for Argus Safety.

Generated and reviewed Computer System Validation (CSV) deliverables in compliance with 21CFR Part 11, GxP and FDA Compliance Regulations, including Validation Plan and Protocol, Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification,(PQ) Test Scripts, Test Cases and Vendor Assessment Report

Drafted SOPs for all the computerized systems to make them compliant with 21CFR Part 11 Rules and updated all the existing procedures, and trained users on these systems and the implications and impact of 21 CFR 11 compliant data systems on day-to-day functions

Followed the Standard Operating Procedure SOPs of the company in documenting Test Plan, Test Cases and Test Procedure using Business requirements document and Functional requirements document of the system.

Managed company’s Electronic Document management systems, ensuring classification of records and implementation of access controls of project workspaces, adhering to company’s Group Records Management policy.

Served as the point of contact for document control function on day-to-day activities, assisted in the planning, development and implementation of the business’ overall document management program to include records management and drawing/document control.

Maintained group access, folder hierarchy, folder defaults, metadata and performed audits of the EDMS to ensure compliance to approved procedures

Provide support for EDMS users in the Regulatory and Clinical groups. Participated in vendor selection for next generation EDMS.

Participated in technical team/network meetings for sharing best practices and setting priorities for future enhancements and system break/fix issues in EDMS.

Assisted in the development and maintenance of business process workflows, supporting project team of document controllers.

Developed and customized workflows, life cycles, jobs and methods using Documentum tools.

BD Medical-CareFusion, El Paso, TX Oct 2013-Sept2014

Verification & Validation Engineer

BD (Becton, Dickinson and Company) is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD Medical is among the world’s leading suppliers of medical devices and is a leader in injection and infusion based drug delivery.

Project: Worked as a Verification and Validation (V&V) engineer for Labware LIMS (Laboratory Information Management System) used for research applications. The project involved gathering the requirements to building specifications and generating protocols in accordance with the FDA (Food and Drug Administration) standards (21 CFR Part 11).

Responsibilities:

Member of assessment team to study the 21 CFR Part 11 requirements.

Wrote the Validation Assessment for the management to understand the importance of validation of core business functionality.

Gathered the User Requirements from the Business Users and the Business Sponsor.

Developed the Functional Specifications based on the Business User Requirements along with the Lead Developer.

Coordinated with the Lead Developer to set up and build the prototype of the application.

Review companywide policies and QA procedures.

Drafted new SOPs and trained all users on the systems, implications and impact of 21CFR Part 11 compliant data systems on day-to-day functions.

Created a Validation Plan based on the Project Scope, Testing Objectives and Testing Plan.

Wrote documentation for all aspects of the computer systems validation lifecycle, in accordance with FDA regulations, particularly Part 11, including: Validation Plan and Protocol, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification.

Created the Test Plan for Protocol Execution and conducted Tester Training for the Test Script Execution.

Configured the Specs and Analysis as per the SOP’s and the relevant Quality standards of the Business User.

Set up the Exception Report Database and coordinated with the Lead Developer to resolve the bugs that was found.

Maintained the Requirements Traceability Matrix (RTM).

Actively participated in project meetings and discussions.

Peer review deliverables from project team members

Scheduled and documented the formal and informal software design reviews

Set-up, assessed and analyzed the samples, and processed the data using various data reduction and Laboratory Information Management System.

Neuland Laboratories, India Aug 2010- Sept 2013

Validation Engineer

Neuland is a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry for chemistry related services.

The Project involved in process validation various manufacturing equipment.

Involved in Qualifying the Documentum system functionality according with 21 CFR part 11 requirements like Security, Audit Trail etc.

Reviewed and modified existing Standard Operating Systems (SOPs) for System Use SOPs.

Wrote and reviewed IQ and OQ protocols.

Involved in writing and reviewing Requirement Traceability Matrix (RTM) to track User and Functional Requirements.

Wrote Validation Summary Report (VSR) in compliance with 21CFR Part 11 regulations.

Prepared the Test Cases by going through User Requirement Specification, Functional Requirement Specification and Design Specification.

Performed extensive Manual Testing and Black Box Testing of the application.

Prepared Test Cases for Functional testing, Integration Testing, and User Acceptance testing(UAT).

Conducted positive and negative testing manually.

Responsible for writing test plans, Test scripts. Verified test results, and prepared Test Summary Reports.

Involved in generation and implementation of QA and QC procedures and policies.

Responsible for updating weekly status reports, by mentioning the progress of Manual Testing effort and open issues resolved.

Worked on a parallel project involving Data Migration

EDUCATION:

Master’s in Chemical Engineering, Lamar University, Texas

Bachelor’s in Chemical Engineering, JNT University India

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