SUMMARY

• 8+ years of experience in Validation Engineer/CSV/Quality and noledge of FDA 21 CFR Part 11, 21 CFR Part 210, 211 and GxP Regulations.
• Knowledgeable of common instruments and equipment used in an analytical laboratory.
• Working experience with ensuring compliance to Part 11, GAMP5 and ICH guidelines
• Good noledge of Software Development Life Cycle (SDLC) with Waterfall andAgilemodels
• Experience with the IT project/platform compliance/validation strategy forGxP& Non - GxPprojects.
• Hands on experience in analyzing the documents, classifying them into predetermined sub-classes according to theRegulatoryspecifications of the Client and FDA.
• Experienced in preparing Risk Assessment, Remediation Plan and Deviation Reports for FDA regulated environment
• Extensively used SQL statements to query the Oracle Database for Data Validation and Data Integrity noledgeable of ISO 9001:2015 ISO 13485:2016 Software applications which support quality management system processes, design and development processes need to be validated.
• Skilled in developing Standard Operating Procedures (SOP's), policies and working instructions to comply with FDA regulations
• Performed Regression, System and UAT testing using both HP Quality Center and HP Application Life Cycle Management (HP ALM) and paper based manual testing
• Experienced in Software Development Life Cycle (SDLC) Waterfall and Agile methodologies, Manual Testing, and Black Box Testing, Validation and Verification testing.
• Experience of developing Standard Operating Procedures (SOPs), test plans, test cases and validation deliverables including VMP, IQs, OQs, PQs, VSR, Requirement Traceability Matrix
• Excellent noledge of testing methodologies, strategies and Software Development Life Cycle (SDLC)

PROFESSIONAL EXPERIENCE

Confidential, OH

Validation Specialist

Responsibilities:

• Oversee the qualification of process automation systems, laboratory and manufacturing instruments, manufacturing execution systems, databases, and IT infrastructure.
• Interface with Engineering, Validation, and end user groups as a QA subject matter expert to provide technical validation guidance related to GxP compliance, design and requirements development, software testing, system administration, data management, and risk-management.
• Oversee the development, implementation, and maintenance of site procedures and policies for Computer System Validation, aligning with global policies and procedures.
• Review and approve validation plans, qualification protocols and test scripts, user acceptance testing, reports, change management, and authorization for use documentation.
• Ensure that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation Master Plan (VMP) adherence.
• Review and approve exceptions associated with the qualification and startup of the Devens Cell Therapy Facility and participate in resulting investigations and correction / corrective action planning.
• Verify compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.
• Reviewed test cases and scripts and documented the results as per the FDA regulations.
• Validation Subject Matter Expert for CSV activates performed by functional areas (e.g. analytical laboratory, manufacturing).
• Involved in verification and validation of technical and functional design specifications.
• Proficient in handling validation deliverables in Valgenesis. Involved in reviewing and approving Validation deliverables on Valgenesis.
• Prepared SOPs for the Administration and Operation of the Validation of Manufacturing Execution System (MES)
• Identified the applicable CSV deliverables to the project and drafted the Validation required elements.
• Configured laboratory information management systems, such as LabVantageSQLLIMS,developing validation master plans and validating LIMS implementations
• Facilitated interdepartmental software project delivery for the IT Compliance team and fostered the design and update of Group Policy for GxP compliancedataintegrityproject.
• Workflows implemented included complaints, CAPA and Change Control.
• Based on the User and Functional Requirement specifications (UFRS), added standard analytical tests to the samples using Lab Vantage LIMS.
• Led CAPA investigation, root cause analysis, corrections, corrective actions, preventive actions, effectiveness checks.
• Used HP ALM for the testing and also for tracking and reporting test defects.
• Performed CSV development and execution of DeltaV IQ Phase and OQ testing activities for the DeltaV Process Control System at the new Biotechnology facility.
• Facilitated interdepartmental software project delivery for the IT Compliance team and fostered the design and update of Group Policy for GxP compliancedataintegrityproject.
• Responsible for testing strategy, Test Plan & Protocol, IQ, OQ, PQ, RTM, and Validation Summary
• Analyzed test scripts to check whether all functionalities has been covered within the compliance of design control requirements as defined within 21 CFR Part 11.
• Developed IQ, OQ and PQ for checking the data integration between LIMS and other applications.
• Analyzed and reviewed validation deliverables like Validation Plan, Risk Assessment, Validation Summary Report in compliance with 21 CFR Part 11, GAMP 5 and GMP FDA Compliance Regulations.
• Designed the High-Level Risk Assessment for the computerized system concerning regulatory, legal and information security topics from GxP, SOX and HIPAA requirements.
• Understood and complied with regulations of 21 CFR Part 11, Annex 11 and all company processes as outlined in Standard Operating Procedures (SOPs)

Confidential, PA

CSV Engineer/Validation Specialist

Responsibilities:

• Assisted in planning and documenting validation project plan, reviewing engineering reports and risk assessment to identify gaps and recommending necessary development.
• Analyzed and reviewed validation deliverables like Validation Plan, Risk Assessment, Validation Summary Report in compliance with 21 CFR Part 11, GAMP 5 and GMP FDA Compliance
• Represent and assure the external audit readiness and inspections for theGxPSystems.
• Providing training (e.g. SOPs) on an annual basis and maintaining training records as new procedures becomes effective. Carrying out duties in compliance with all SOPs, Pharmaceutical regulations such as 21 CFR Part 11 and FDA regulations, cGMP, GLP, GCP,ICH, USP and European regulations guidelines.
• Documented Validation Plan, Validation Summary Report for SAP roll outs and implementing interfaces between SAP and other manufacturing systems.
• Approve SDLC defects closure with relevant root causes and suitable CAPA in JIRA &HP ALM.
• Involved in writing and executing test cases and test scripts to validate certain functionalities of LIMS
• Providing training (e.g. SOPs) on an annual basis and maintaining training records as new procedures becomes effective. Carrying out duties in compliance with all SOPs, Pharmaceutical regulations such as 21 CFR Part 11, 210, 211, and FDA regulations, cGMP, GLP, GCP,ICH, USP and European regulations guidelines.
• Led gap analysis, process mapping and remediation activities for process validation, CSV and software QA remediation activities per consent decree work plan.
• Reviewed and updated end to endvalidationdocumentation forTrackWiseto ensure compliance with company policies and procedures
• Reviewing JIRA SAP ticket system and verifying consistency / traceability throughout the SDLC documents.
• Creating test cases and test cycle onJIRA. Raising new bugs and validating existing defects
• Preparing aDataMigrationSummary Report stating thedatamigrationactivities taken place while loading the staticdatain the LIMS application.
• Responsible for generating and reviewing CSV deliverables in compliance with 21CFR Part 11 and GxP FDA Compliance Regulations.
• Reviewed their current SOPs and modified to suit the GMP guidelines and entered inHPALM.
• Configured laboratory information management systems, such as LabVantageSQLLIMS,developing validation master plans and validating LIMS implementations
• Facilitated interdepartmental software project delivery for the IT Compliance team and fostered the design and update of Group Policy for GxP compliancedataintegrityproject.
• Workflows implemented included complaints, CAPA and Change Control.
• Based on the User and Functional Requirement specifications (UFRS), added standard analytical tests to the samples using Lab Vantage LIMS.
• Led CAPA investigation, root cause analysis, corrections, corrective actions, preventive actions, effectiveness checks.
• Analyzed test scripts to check whether all functionalities has been covered within the compliance of design control requirements as defined within 21 CFR Part 11.
• Involved in all activities in SDLC life cycle.
• Wrote SDLC deliverables including change requests, validation master plans, test plans, implementation plans, data migration plans, user/system requirements, design, test documents, and traceability matrices for multipleGxPsystems.
• Analyzed User and Functional requirements to develop Test Plans, Test Cases and Test Scripts usingHPALMand executed them. Executed validation test cases based upon system requirement and FDA standards. Tracked and closed the defects usingHPALM.
• Followed Computer Systems Validation (CSV) Master Plan to author, review and approve CSV deliverables for systems as per GxP (GLP, GCP and GMP) FDA Assessment.
• Provided leadership in the efficient application of the Quality System Regulation, (QSR) as it applies to the R&D efforts at a facility dedicated to the R&D function up through and inclusive of Design Transfer.
• Validated computerized laboratory equipment based on GAMP 4 & 5.
• Performed validation activities for applications like LIMS, MES, manufacturing software and various Stand-alone equipment using HP ALM.
• Provided FDA 21CFR Part 11 Documentation Remediation for corporate-wide Clinical Trial System
• Involved in all phases ofSDLCaccording to Company procedures, FDA Guidelines, GMP and (21CFR Part 11).

Confidential, Tarrytown, NY

CSV Engineer/Validation Engineer

Responsibilities:

• Led Risk assessment (FRA) under GMP andGxPpolicies and in compliance with 21 CFR part 11 and Annexure 11 determining the functionalities are FDA regulated.
• Reviewed their current SOPs and modified to suit the GMP guidelines and entered inHPALM.
• Documented end to end validation process for IRMS,TrackWise(CAPA, CCM) to ensure compliance with company policies and procedures.
• Managed implementation, validation support ofTrackWise, to manage CAPA, Deviation & Change Control.
• Involved in developing detailed Test Plan, Test Cases and Test Scripts usingHPALMfor Functional, and Regression
• Reported bugs, verified the issues and re-executed the test cases using Bug tracking ToolJIRA
• Analyzed and reviewed validation deliverables like Validation Plan, Risk Assessment, Validation Summary Report in compliance with 21 CFR Part 11,GAMP5 and GMP FDA Compliance Regulations
• Guided the project team in completing the required validation deliverables/ activities in each phase ofSDLC.
• Ensure ongoing compliance with quality management system and maintain a high ethical standard and enforce data integrity.
• UpdatedSOP’s and also participated in interim controls assessment
• Represent and defend validation programs to client auditors andregulatoryauthorities.
• Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis. Analyzed safety and efficacy data from Phase II and III clinical trials.
• Participated in trouble shooting and triaging of issues with different teams to drive towards root cause identification and resolution usingJIRA
• Author requirements for computer systems to ensure compliance with regulations such as 21 CFR Part 11,SOX, Annex 11, and cGMPs.
• PerformedDataIntegrityAssessment of the Manufacturing, Quality and GxP process.
• Provided guidance and support for developmental stability programs on new products, technical transfers and change controls supporting compliance andregulatoryrequirements.
• Guided the team in implementation of SAP, LIMS and multiple in-house applications.
• Performed the ERES assessment of the overall functionalities and evaluated the functionalities with a risk assessment based on the impact to the three core criteria: GMP, product quality anddataintegrityand defined the testing strategy
• Analyzed Requirements and Design Documents forTrackWiseprojects to understand system functionality which halped in authoring and reviewing of different validation documents
• Executed Test procedures inHPALM(Application Lifecycle Management) and assisted in Validation testing using Unix/Linux environment
• Implement production changes while adhering to standardizedchangecontrolprotocols.
• Worked on GAMP, GxP's (GCP, GLP, GDP and GMP), and 21-CFR Part 11 regulation of Electronic Records, Electronic Signatures and Audit Trails.

Confidential, Boston, MA

CSV Engineer/Quality

Responsibilities:

• Drafted the Risk Assessment underGAMP5, 21 CFR Part 11, URS for the new internal QMS, inventory
• Prepared documentation for all aspects of the Computer Systems Validation (CSV) lifecycle, in accordance with FDA regulations, particularly 21 CFR Part 11
• Performed Detailed Risk Assessment by Failure Mode Effects Analysis (FMEA) for managing the risk levels used before validating the system.
• Authored, executed and documented system change requests and validations for support of analytical instrumentation and computerized systems
• Involved in performing the GAP Analysis of the system. Developed Risk Assessment and categorized them according to the criticality
• PrepareDataMigrationPlan includingmigrationrisk, milestones, quality and business sign-off details.
• Performed and collaborated on various IT Compliance activities - Vendor Requalification, Disaster Recovery,SOXCompliance, Periodic Review, Training, Review of CAPA's, Trending on halpdesk tickets, etc
• Analyzed the Business requirements and assisted in preparing the Validation Master Plan by developing the user requirements
• Review to make certain all data is correct in accordance with GXP, DEA, FDA and ICH guidelines.
• Documenting OQ and PQ test scripts for new functionality and modifying existing test scripts, execution and SOP development
• Identified all regulatory constraints as identified by GxP, GCP, and 21 CFR Part 11 and technical constraints as documented.
• Managed traceability between requirements, design elements, and test cases in HP ALM.

Confidential - Warrendale, PA

Validation Engineer

Responsibilities:

• Reviewed and developed validation deliverables- master plan/Summary Report, URS, FRS, Requirement traceability matrix (RTM), IQ, OQ and PQ protocols
• Perform Verification and Validation testing in an FDA/UL regulated environment.
• Documentation of incidents and resolution, including generating change control packages
• 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
• Prepared Validation Master Plan (VMP) for validating analytical laboratory equipment's and LIMS.
• Involved in defect development life cycle (HPQC) and assigned the created defects to developers. Once the defect is fixed, Retested the defect and it moved to the closed status.