SUMMARY

• 3+Years of Experience as a Validation Engineer with Hands on experience in Test Method, Process Validation, Software testing, supplier Quality, CAPA Expert, Quality Auditor, Validation & manufacturing expert.
• In - depth knowledge and understanding of Validation Life Cycle, Software Development Life Cycle (SDLC), Agile Methodologies and Computer Systems Validation, Design Verification Engineer to perform Remediation.
• Senior Validation Engineer with over experience in the regulated pharmaceutical, Biotech and Medical Device industries.
• Good knowledge of Design Verification Engineer to perform Remediation of medical product lines.
• I nvolved in P ro ce ss Va li da ti on a nd Te st M e thod Valid at ion .
• Good knowledge on Quality System Regulations for medical devices and pharmaceuticals such as, 21 CFR Part 11, 21, 210, 211, 820, ISO 13485, 9000, 14971; cGxP (GMP/GCP/GDP/GLP)
• Strong experience in Change Control Management System (CCMS), Laboratory Information Management System (LIMS), Enterprise Document Management System (EDMS).
• Used statistical tools (Minitab) to analyze data, make acceptance decisions and improve process capability (Six sigma, SPC, DOE).
• Coordinated and monitored the Company's CAPA program to assure CAPAs are properly generated, and corrective or preventative actions are identified, and effectiveness checks successfully completed in a time frame consistent with Company policy.
• Authored TMV (Test Method Validation protocols) and coordinated for executing protocols with operators.
• Performed gap analysis post 3rd party quality audit; wrote critique of equipment and process validations protocols and reports. Perform risk evaluation of PFMEAs for process validations.
• Writing Validation Protocols such as IQ, OQ, PQ for process and equipment validations.
• Demonstrated expertise in writing and executing all validation deliverables such as compliance/validation plans, validation reports and summaries.
• Involved in validation process and preparation of validation master plan (VMP).
• Experience in conducting GAP Analysis and developing remediation plans, Validation Master Plans (VMP), Validation Summary Report (VSR), and Requirement Traceability Matrix (RTM).
• Proficient in working with laboratory analytical instruments including gas chromatography, UV spectrophotometer, pH Meter, incubator, sterilization units, autoclave.
• Have excellent communication (written and verbal) and analytical skills.

TECHNICAL SKILLS

Software: SolidWorks, Creo, Abaqus, MATLAB, LabVIEW

Validation Deliverables: VTP, VMP, URS, FRS, DS, IQ, OQ, PQ, VSR.

Regulations: 21 CFR Part 11 (210/211, 820), GAMP, cGxP (GMP/GDP/GLP)

Applications: EDMS, QMS, LIMS, ERP

Hardware: Stratasys, Object, Flash forge finder, Instron

MS Office programs: Excel, Word, PowerPoint.

Programming Language: C, C++

Statistical Tools: Minitab

PROFESSIONAL EXPERIENCE

Confidential

Validation Engineer

Responsibilities:

• Involved in developing, reviewing and executing Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) for various manufacturing/packaging equipment.
• Performed Calibration & Verification with the help of Kaye AVS Validator to calibrate Thermocouples.
• Performed Cycle Development, Operational (OQ) and Performance (PQ) Qualification using thermocouple and temperature mapping studies of Autoclave.
• Calculation and Interpretation of data for Equipment Validation.
• Involved in Preparing documentation for all aspects of the validation, in accordance with FDA design control & Regulations, GDP (Good Documentation Practices), GMP (Good Manufacturing Practices).
• Involved in developing Corrective Actions & Preventive Actions (CAPA) to prevent future failures and quality issues.
• Review and Developed validation deliverables - IQ, OQ, PQ protocols and Validation Summary Report.
• Created and maintained documentation for the project Worked on Validation of LIMS system including interfaces between Lab instruments and LIMS.
• Based on the User and Functional Requirement specifications (UFRS), added standard analytical tests to the samples using Lab Vantage LIMS.
• Developed the Data Migration Plan and Reports which states that the data migration activities have taken place while loading the static data in the LIMS application.
• Prepared work flow diagrams and process charts using MS Visio for the training modules for LIMS applications.
• Involved in managing Sample Manager, Instrument Performance, Reagents Management and Folder Manager Modules with the LIMS application.
• Developed the Validation Summary Report which summarizes the validation activities that were performed for the LIMS application.
• Worked with the reliability, maintenance, to resolve the issues encountered during the execution of the test steps.
• Worked with quality and manufacturing engineers to fix the deviation and non-conformance reports using various validation strategies.
• Generation of Validation Summary Report to summarize and document all validation activities.
• Conducted GAP analysis from CAPA documents and failure investigation files and developed a Traceability Matrix to reflect the GAPs.
• Traced User Requirements in Traceability Matrix Document during the entire validation.
• Designed the 21 CFR Part 820 Assessment plan for manufacturing and test equipment as well as involved in developing Requirements Traceability matrix.
• Performed CAPA investigations and CAPA documentation.

Confidential

Validation Engineer

Responsibilities:

• Developed and executed protocols including equipment installation qualifications (IQ), operational qualifications (OQ), and process qualifications (PQ) activities as required for qualification and validation of products and processes.
• Responsible for Test Method Validation (TMV) and Gage Repeatability & Reproducibility (Gage R&R) studies for equipment under remediation environment.
• Provided guidance and direction for sample size and statistical analysis of verification and validation test requirements and results.
• Evaluated and completed non-conformance reports, product complaints, CAPA’s and field actions and analyzed if they should be escalated to a CAPA.
• Assisted with the investigation of Corrective/Preventive Actions (CAPA) to determine the root cause using fishbone diagram, 5Whys, etc.
• Reported trends in Deviation and CAPA records to monitor performance for continuous improvement.
• Identified and created trend analysis for key quality performance indicators and CAPA effectiveness monitoring.
• Worked closely with the investigation team and lead investigators to assess CAPA effectiveness and develop effective CAPA Plans.
• Responsible for maintaining quality system regulations (part 820) and regulatory standards (ISO 13485/14971 ).
• Participating in developing EU MDR Documentations for Notified Bodies.
• Leading and performing annual product reviews (APRs) of all commercial products followed by maintenance of Track Wise APR database.
• Wrote Gap Analyses for ISO 13485:2016 and EU MDR. Supporting EU-MDR initiatives.
• Review and approve supplier's process validations per standards with 21 CFR parts 803, 806, and 820 and ISO 13485.
• Performed statistical analysis of process data - DOE, process mapping, IQ/OQ/PQ, control plans, and summary reports via Minitab.
• Meet highly stringent document quality standards adhering to FDA standards for the medical field and knowledge of medical device (21CFR parts 803, 806, and 820 & ISO 13485) regulatory standards.
• Train technicians on Standard Operating Procedures (SOP's), Work Instructions and Good Documentation Practices (GDP's).
• Evaluated and completed non-conformance reports, complaints, CAPA's and field actions and analyzed if they should be escalated to a CAPA.
• Non-conformance identification and evaluation. Perform NC investigations which includes, Event description, containment activities, root cause analysis, Disposition and corrective/ Remedial actions.
• Evaluated equipment and analyses process outputs for stability and repeatability using statistical methods to make improvements when necessary.
• Ensured that all products/processes to be developed comply with GMPs, FDA, and other regulatory.