1. Jimmy Vale
Email : jimmyvaleval@gmail.com
Mobile :732-630-3972
PROFESSIONAL SUMMARY
• 6 Years Experience in Validation Engineering in FDA regulated Pharmaceutical environment
with concentration in Computer System Validation (CSV), Process Validation, Equipment
Validation, Laboratory Instrument Control System, Technical Writing, and Testing.
• Excellent knowledge in Computer Validation Life Cycle, Software Development Life Cycle,
Manual Testing, and Automated Testing.
• Professional experience in validation practices with good understanding of GAMP 5, cGxP
(cGMP, cGLP, cGDP, and cGCP) standards, Corrective and Preventive Actions (CAPA)
Investigation.
• Extensive knowledge of FDA 21 CFR Part 11: Electronic Records and Electronic Signatures
• Good understanding and practical knowledge on GAMP5 regulations
• Excellent knowledge and good working experience on preparing the Risk Assessment
documents
• Expertise in developing and documenting all the aspects of Validation Master Plan (VMP),
Standard Operating Procedures (SOP), Installation Qualification (IQ)/Operation Qualification
(OQ)/Performance Qualification (PQ), and Validation Summary Report (VSR)
• Experience in developing User Requirement Specifications (URS), Functional Requirement
Specifications (FRS), Software Design Specifications (SDS), Hardware Design Specification
(HDS), and User Manuals of all the computerized systems and Laboratory instrumentation.
• Strong working knowledge of Windows Servers and Operating Systems
• Excellent knowledge on working principles of COTS Instrumentation
• Strong analytical, debugging, troubleshooting skills and quick learning abilities
• Experience in developing and writing Requirements Traceability Matrix (RTM)
• Excellent working knowledge in Laboratory Information Management Systems (LIMS),
Documentum, Scientific Data Management System (SDMS), and Adverse Event Reporting
System (AERS)
• Experience in writing and developing Test Plans, Test Cases, Test Scripts, Test Criteria, Test
Procedures, and Test Summary Reports of all the laboratory equipments
• Involved in writing the User Acceptance Test Summary Report
• Skillful in carrying out Gap Analysis and performing Remediation Planning
• Experience in automated testing tools such as Mercury Quality Centre (MQC) and Quick
Test Professional (QTP)
• Tracked and documented Change Requests using Mercury Quality Center
• Excellent documentation skills in compliance with Good Documentation Practices (GDP)
• Excellent Organizational, Interpersonal, Written, and Oral communication skills
TECHNICAL SKILLS:
Computer System Validation: GxP, CFR (11, 210, 211, 820), GAMP 5
Analytical Software’s: LIMS, Documentum, AERS, and SDMS
Operating System: MS DOS, Windows 95/98/2000/2003/XP/Vista
Testing Tools: Mercury Interactive Win Runner, Load Runner, QTP
Bug Tracking Tools: Quality Center, Test Director.
Laboratory Equipments: Gas Chromatography/Mass Spectroscopy (GC/MS) Liquid Chromatography
(LC), Atomic Absorption Spectrometer (AAS), Scanning Electron Microscope (SEM), Atomic Force
Microscope (AFM), Differential Scanning Calorimeter (DSC)
Applications/Engineering Tools: Microsoft Office, Adobe Photoshop.

2. Jimmy Vale
Email : jimmyvaleval@gmail.com
Mobile :732-630-3972
PROFESSIONAL EXPERIENCE:
Eisai , NJ Oct 2015 – Present
Validation Analyst
The project involves the Retrospective Validation of the Legacy System called the Inventory
Management System (IMS).
Responsibilities:
• Performed requirements gathering sessions with users for Inventory Management System (IMS)
• Prepared list of documents required for the IMS legacy system based on GAMP 5
• Recommended Validation Deliverables and level of testing to be conducted for the IMS system
• Conducted GAP Analysis in order to be in compliance with 21 CFR Part 11
• Created and maintained the project plans. Presented the project plan and associated project
schedule to the project team for review and input
• Prepared documentation for all the aspects of Validation in accordance with 21 CFR Part 11
regulationsProvide guidance on best practices to follow guidelines set by the FDA for electronic
systems as defined in 21CFR Part 11
• Review documents related to Quality Systems such as User Training Materials
• Involved in preparing Remediation Plan for the IMS Legacy System
• Designed and authored Standard Operating Procedures (SOPs) for Validation Master Plan (VMP)
and Validation Protocols
• Developed and authored the Validation Master Plan (VMP) for IMS and LIMS
• Remediation Plans were developed for the components that were not fully and mostly compliant
• Excellent understanding of various Inventory Management Systems and how their components
are interfaced together to facilitate seamless transition of data within a particular domain
• Review internal documentation for compliance with regulations and industry guidelines
• Participated as a team member to draft a Remediation Plan for Project Management approval
after Gap Analysis for IMS System
• Create validation schedules; coordinate execution efforts with operators, engineers, lab scientists
and quality assurance staff members
• Wrote the Validation Assessment for the management to provide them a brief review of
objectives to be covered during validation of IMS system
• Involved in Retrospective Remediation project and Gap analysis. Responsible for creating the
Corrective and Preventive Action Plan (CAPA) and performed the Gap analysis to remediate
audit findings and observations given by the auditors for regulated Research and Development
(R&D) applications
• Developed Standard Operating Procedures referring to CFR Part 210 and 211
• Analyzed the requirements and critical areas of the IMS application to setup and execute baseline
tests
Allergan Pharmaceuticals, CA Jan 2014 – Sep 2015
Validation Analyst
Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic
advances to help patients live life to their fullest potential. Project involves implementing the Electronic

3. Jimmy Vale
Email : jimmyvaleval@gmail.com
Mobile :732-630-3972
Laboratory Notebook (ELN) development and associated activities (i.e. integrating with various other
systems, security, and regulatory compliance etc) as well as documentation requirements and validation
activities aligned specifically for the project. ELN system is intended to automate the manual processes
and provide an electronic platform for recording generalized laboratory experiments in support of
formulation development.
Responsibilities:
• Ensured the adherence to Allergan SDLC and application development policies and procedures.
• Coordinated with the ELN Development team and Infrastructure team to facilitate discussions
around the technical aspects of the system, as defined by the project plan.
• Administered updates to the User Requirement Specifications.
• Responsible for design and construction of the delivered system to fully meet the defined user
requirements.
• Responsible for Validation Plan development, review, approval, and maintenance.
• Administered changes required to the validation deliverables for the system.
• Supported the assembly of the Functional and Design Requirements Specification documents.
• Owned and oversee the development of validation documentation.
• Responsible for project management activities related to testing.
• Prepared the Validation Protocol development, review, and approval.
• Testing documentation development, review, pre-approval, execution, and post-approval of IQ,
OQ, and PQ.
• Prepared the Summary Report development, review, and approval.
• Acted as primary member with ELN Team representatives and Subject Matter Experts to develop
system requirements
• Coordinated with Infrastructure Team to develop HW/SW design for system implementation.
• Assisted Business Analyst in the assessment and gathering of supporting documentation, such as
Test Method SOPs, Material Specifications, Test Data Sheets and Reports, etc.
• Assisted Development Team with configuration of the Formulator ELN product.
• Facilitated Change Control processes related to application or system updates made to the
production system.
• Developed system-specific Standard Operating Procedures (SOPs) for the utilization of the ELN.
Gilead Sciences, CA Mar 2012 – Dec 2013
Validation Analyst / Compliance Specialist
Gilead Sciences, Inc. is a research-based biopharmaceutical company. The project involved validation of
the Pharmacovigilance Drug Safety Database System ArisG, a web based application for Adverse Events
Reporting System (AERS) and developing Validation Protocols and Summary Reports. The system also
contained 3500, 3500A forms and generated MedWatch safety reports.
Responsibilities:
• Developed Process flow diagrams for Case Processing, Distribution, and Reporting.
• Involved in configuration of the ArisG System using Oracle database at backend.
• Conducted vendor audit

4. Jimmy Vale
Email : jimmyvaleval@gmail.com
Mobile :732-630-3972
• Executed testing of E2B and non E2B data elements by modifying/importing XML files to ensure
system functionality and data mapping with respect to the Case Report Form (CRF) is as per ICH
guidelines.
• Collaborated with subject matter experts and business users to ensure the flow of data throughout
the CRF satisfies the requirements for FDA regulations and EU regulations.
• Conducted vendor audits to ensure that the system is in compliance with the regulatory guidelines
set according to the industry standards.
• Coordinated system development, onsite/offshore/user acceptance testing, and defect resolution
using HP Quality Center.
• Involved in 21 CFR Part 11 compliance assessments.
• Understood the Clinical Trial Process along with various study configurations involved in the
process.
• Collaborated with the Corporate Quality Team and Validation Team to setup a change request
process for the project.
• Involved in creating training material and Standard Operating Procedures.
• Developed Requirements Traceability Matrix (RTM) to keep track of the changing requirements.
• Maintained open communication and conducted peer review within the Technical Writer group to
ensure standardization and quality deliverables across the program.
• Developed Test Summary Report (TSR).
• Participated in preparing and presenting weekly presentations for the progress of the project.
Bayer Pharmaceuticals, CT July 2011 – Feb 2012
Validation Analyst / Compliance Analyst
Project involves process design, process development, equipment design & qualification, process scale-up
and process validation. The project involved writing and reviewing SOP’s for various processes and
equipment’s. Developing a new Cost-effective Cleaning procedure for cleaning the facilities in the plant
and validation of the cleaning procedures.
Responsibilities:
• Prepared Validation protocols for Equipment Qualification and Cleaning Validation.
• Issued and reviewed standard operating procedures (SOP) for various processes and equipments.
• Developed a new cost-effective Cleaning method for cleaning the making & finishing systems in
the manufacturing plant and Validated it.
• Validated laboratory equipments in QC Analytical & Microbiological Lab.
• Developed Validation Protocols, Summary reports for Validating QC laboratory equipment.
• Extensively used Electronic data management system (EDMS) for storage, retrieval and tracking
versions of all the Validation documents for the different processes and equipments.
• Executed the formula design of experiments (DOE) for a new deodorant stick development using
Minitab Software and worked on product and process development.
• Formulated and prepared batches for UAP (Underarm Perspirant), Deodorants and Gels for R&D
and consumer testing.
• Executed process scale-up for antiperspirants, gels and deodorants by using a software program
and preparing batches.
• Executed stability and quality tests on various products and materials in Quality Control
Laboratory.

5. Jimmy Vale
Email : jimmyvaleval@gmail.com
Mobile :732-630-3972
• Responsible for quarterly reporting on Pilot Plant Production which included analysis on all of
the products manufactured and their manufacturing processes.
• Efficiently worked on projects and production areas focusing on line support, cost reductions,
reduction of downtime, corrective & preventive actions, troubleshooting, material handling,
project management and process development.
• Adhered to OSHA and other safety regulations like proper waste disposal techniques.
GlaxoSmithKline, PA June 2010 – May 2011
Validation/QA Engineer
As a Validation Engineer, my role was to design and to troubleshoot the laboratory instrument control
system equipments application and the documentation process involved in validating the IT and
Laboratory Equipment systems in compliance with 21CFR Part 11 and cGMP guidelines.
Responsibilities:
• Worked in a strictly regulated GxP (cGMP and cGLP) environment
• Provided IT technical expertise to Engineering and Manufacturing operations
• Reviewed and analyzed Customer/User requirements/ Function Specifications based on flow
diagrams and business requirements
• Experience with client operating systems (Windows 2000, XP, Vista) Involved in up gradation of
the software’s of the laboratory instrumentation and overcame the technical obstacles
• Defined solution system boundary & identified all regulatory constraints as identified by GxP,
GCP, and 21 CFR Part 11 and technical constraints as documented
• Developed Validation Master Plan and test plan of this project
• Involved in maintaining the electronic records in compliance with 21 CFR Part 11 regulations
• Ensured strict compliance with standards and templates in relation to the writing of Technical
Documentation
• Maintained all the logs, documents through a document management system Documentum
• Developed IQs, OQs, and PQs for validating LIMS environment and laboratory instrumentation
for FDA compliance in a strictly regulated environment
• Ensured validation of Core components and Custom components of LIMS in compliance with
FDA regulations
• Developed SOPs for all the laboratory equipments in a strict compliance with FDA regulations
• Performed Gap Analysis and developed Remediation Plan so that the system was in compliance
with both cGLP and cGCP
• Used Documentum to store and retrieve LIMS data and other components
• Coordinated the entire Validation Life Cycle
• Manual testing for LIMS software used to manage large volume of data of laboratories in
compliance with cGLP
• Reported bugs and change request with the help of the change request form
• Created Requirement Traceability Matrix which helped to see whether the user requirements were
met with Business requirements
• Conducted User Acceptance Testing and documented UAT summary reports

6. Jimmy Vale
Email : jimmyvaleval@gmail.com
Mobile :732-630-3972
• Organized, developed, and managed multiple tasks with effective time management
• Conducted meetings to discuss compliances with the FDA rules and regulations
EDUCATION:
• Bachelor in Chemical Engineering, Texas A & M University, Kingsville, Texas

7. Jimmy Vale
Email : jimmyvaleval@gmail.com
Mobile :732-630-3972
• Organized, developed, and managed multiple tasks with effective time management
• Conducted meetings to discuss compliances with the FDA rules and regulations
EDUCATION:
• Bachelor in Chemical Engineering, Texas A & M University, Kingsville, Texas