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Validation Analyst Resume

Ann Arbor, MI

PROFESSIONAL SUMMARY:

  • Motivated and results oriented engineer by increasing responsibility in diverse functions within the Engineering Applications by developing, executing and managing improvements to product design, manufacturing processes / Operations and Quality Systems.
  • Around 7 years of extensive and comprehensive experience as a Software Validation Engineer/Manufacturing Engineer in pharmaceutical environment with emphasis on Computer Systems Validation (CSV), Equipment validation and Technical documentation as per Confidential /ISO 13485 and GAMP regulations.
  • Expertise in developing and generating IQ, OQ, PQ protocols for manufacturing and packaging equipment qualifications.
  • Documentation for computer System Development Life Cycle, Regulatory Compliance and Confidential regulations 21CFR, part 11, 58, 210, 211, and 820.
  • Experience executing OQ/PQ for automated equipment including: packaging equipment for bottle packaging lines.
  • Review cGMP documents for compliance to company SOPs, quality systems and regulatory requirements.
  • Working experience of Track & Trace, Packaging line equipment, and serialization solutions.
  • Experience in authoring, reviewing and auditing project documentation for validation protocols that includes Validation Master Plan (VMP), test plan and test cases, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Standard Operating procedures (SOPs), Process Design Document, Risk Classification Document and Validation Summary Report (VSR)
  • Experience in conducting automated testing, traceability matrix and defect management.
  • Good understanding of Lean six sigma methodology, Root cause analysis, Corrective and preventive action (CAPA) and Failure Mode Effect Analysis (FMEA).
  • Experience in performing FMEA analysis, Gap Analysis and Risk Assessment.
  • Knowledge of Corrective and Preventive Action (CAPA) Gage R&R. Root Cause Analysis and Design of Experiment (DOE).
  • Knowledge and experience of using analytical lab instruments such as Centrifuges, Autoclaves, Incubators, UV Spectrophotometers and HPLC
  • Experience in authoring and reviewing requirements and test scripts and test cases as per SDLC methodology
  • Experience working with stakeholders and facilitate communication between client and IT department.

TECHNICAL SKILLS:

Computer System Validation: 21 CFR Part (11, 50, 56,210,211,820), cGxP (cGMP, cGDP, cGLP), GAMP5, IQ, OQ, PQ, RTM, Summary Reports, Audit Trails, Gap Analysis and Remediation Plans, FMEA,LIMS

Testing and Tracking Tools: HP Quality Center(HPQC), Win Runner, Trackwise EQMS, Documentum (PDOCs), Solution Manager, JIRA,QTP, SAS

Databases: Oracle

Methodologies: Waterfall, RUP, Agile, SDLC and GRC

Scientific Software: Working Exposure to Lab view, MATLAB, Eagle and Tina Pro

Languages: C, C++,HTML, SQL

Other Tools: MS Office, MS Visio, SharePoint

PROFESSIONAL EXPERIENCE:

Confidential, Ann arbor, MI

Validation Analyst

Responsibilities:

  • Sr. CSV engineer experience in Medical Devices with knowledge or experience in Confidential Quality System regulation, including Confidential guidance on the General Principles of Software Validation.
  • Involved in preparation and documentation for all aspects of the computer system validation to ensure compliance in accordance with cGxp (cGMP, cGLP and cGCP) and Confidential rules and regulations.
  • Followed Computer Systems Validation (CSV) Master Plan to author, review and approve CSV deliverables for systems as per GxP (GLP, GCP, GMP, GDP, cGMP) Confidential Assessment.
  • R responsible of developing Serialization Design and Manufacturing Documentation. (e.g. Design Specification, Functional Specification, Global SOP's, Navigations Guides, Supporting design documents).
  • Involved in preparation and documentation for all aspects of the computer system validation to ensure compliance in accordance with cGxp (cGMP, cGLP and cGCP) and Confidential rules and regulations.
  • Support computer system validation efforts for system used in GMP, 21 CFR Part 11, and 21 CFR Part 820. Management of CSV project schedule and resources including contract employees.
  • Executed and authored IQ, OQ, PQ and PV protocols within the GMP area for various packaging and process equipment as well as temperature mapping studies.
  • Assured that all system’s validation documentation such as IQ's, OQ’s, and PQ's are in compliance with cGMP's (21 CFR Part 210/211).
  • Design Quality Engineer specializing in design controls, risk management, and process improvement.
  • Involved in writing and execution of test scripts and requirements specification verification documents (RSVs) based on SDLC and GRC methodologies respectively
  • Participate in the collection, analysis, and presentation of data in support of the Corrective and Preventive Action (CAPA) and Management Review process.
  • Created and reviewed Process flow diagrams, Business Integrated Model (BIM), Business Process Master List (BPML), Verification Strategy document (VSD), requirement documents and RTM for the projects
  • Utilized Documentum and created documentation in all phases of the SDLC.
  • Designed and authored Standard Operating Procedures (SOP’s) based on the business requirements gathered for Validation Master Plan (VMP) and Validation Protocols like Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
  • Performed Positive & Negative Testing, End - to-End testing and manual testing
  • ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­Conducted UAT (User Acceptance Testing) to make sure that all the user requirements are catered by the application

Confidential, Mahwah, NJ

CSV/Validation Engineer

Responsibilities:

  • Involved in gathering the User Requirements from the System Owners document for all the software components.
  • Performed Quality Assurance responsibilities by reviewing validation deliverables for various projects for compliance with SDLC, CSV, 21 CFR Part 11 requirements and GxP regulations.
  • Validated computer system interface with laboratory instruments such as Spectrophotometer, GC and HPLC.
  • Made sure all the documentation and the above mentioned responsibilities meet 21 CFR Part 11 Confidential regulations.
  • Involved in performing GAP analysis of the current system and create Remediation Plan for potential risks and failures
  • Handled Product complaints and initiated CAPAs. Involved in the development of cycles for new processes or equipment, which includes development of validation protocols, performing testing and writing validation reports for various equipment.
  • Involved in generation and execution of process validation protocols for oral solid dosage forms.
  • Developed site validation plan by supporting serialization project implementation on packaging lines.
  • Worked in a strictly regulated cGXP environment for all the aspects of Computer Systems and Equipment Validation.
  • Maintained Regulatory compliance with ISO 13845, ISO 14971 Risk Management, Confidential QSR and CMDR.
  • Verified the closure of Event and CAPA Records.
  • Developed and maintained IQ, OQ, PQ protocols for equipments like HPLC, GC, MS, Autoclaves, Freezers, Refrigerators, and other analytical laboratory equipment.
  • Coordinated with the quality assurance team in updating and maintaining the SOPs for laboratory equipment.
  • Performed troubleshooting, data analysis and acted as a regulatory liaison.
  • Maintained the Requirement Traceability Matrix (RTM).
  • Conducted User Acceptability testing and documented the User Acceptance Test Summary Reports (TSR).
  • Contributed towards development of Validation Summary Report (VSR).

Confidential, Philadelphia, PA

Validation Engineer

Responsibilities:

  • Verified if all validation protocols including IQ, OQ, PQ are in compliance with cGMP (21 CFR Part 210/211)
  • Responsible for quality performance monitoring and evaluate internal process to ensure continued delivery of quality products and services.
  • Involved in performing Packaging Validation to identify the defects.
  • Execution and report generation of IQ/OQ/PQ/PV protocols for Liquids and Solid Dosage manufacturing, filling and packaging equipment.
  • Developed Functional Requirements and Test Scripts for large scale SAP ERP implementation, maintaining traceability across design, user and functional requirements, and test protocols.
  • Proficiency in maintaining Risk Management, DFMEA, PFMEA, and CAPA
  • Extensive hands-on experience in performing Process Validation Test protocols (IQ/OQ/PQ) for equipment process in the packaging line, Process Validation Plan (PVP), and preparing PVP Report
  • Good expertise in performing GAP analysis in identifying gaps and correcting them
  • Participated in the preparation and revision of risk assessments using tools such as DFMEA/PFMEA
  • Equipment Validation and technical documentation as per Confidential /ISO 13485 and GAMP regulations
  • Experience in Data Migration, Periodic Review, Change Controls, Change Reporting, Root Cause Analysis, GAP Analysis, CAPA, FMEA and Remediation Process
  • Authored and executed Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Test Method Validation (TMV) for mechanical ces
  • Experienced with Criticality Analysis (CA), Maintainability Information (MI), Fault Tree Analysis (FTA), Event Tree Analysis (ETA), Statistical Process Control (SPC) and Risk Management
  • Maintained CAPA procedure, initiated investigation of non-conformances through root cause analysis, evaluation of the effectiveness of CAPA process, and initiation of action as required improving effectiveness.
  • Monthly status reporting to the management for progress, issues and risks.
  • Preparation of Multiple cGMP Documents such as Commissioning, Validation, Qualification Protocols, SOP, Forms, Vendor Checklists, etc and also document quality issues and quality performance.
  • Prepare, Review and execute Facility Qualification protocols including equipment’s that have been built and installed in compliance with their design specifications and as per OSHA Regulation.
  • Prepared and execute cleaning validation protocol to clean a system or a piece of equipment using method such as Swab Sampling and Rinse Sampling.
  • Monitor the temperature and humidity for the pharmaceutical plant on daily basis.
  • Participated in the assessments for the requirements of 21 CFR part11 and Confidential regulations.
  • Worked with medical and clinical data on annotated CRF, SDTM and ADAM data set level and created tables listing and figures in a format that can be reported to Confidential (Medical Data Acquisition and Storage.

Confidential, Middlesex, NJ

Validation Engineer

Responsibilities:

  • Analyzed and reviewed Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols.
  • Responsible for assisting in the implementation of software systems in compliance with regulatory requirements as they pertain to 21 CFR Part 11 and GAMP 5.0 standards.
  • Authored, reviewed and approved CSV deliverables (validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, and validation Summary Report).
  • Support Quality System development and improvement with respect to GMP systems and development team compliance to ISO and Confidential regulations.
  • Facilitate the implementation of a Quality System which complies with ISO 13485, Confidential 21 CFR Part 820, and other international regulatory guidelines.
  • Assured that all system's validation documentation such as IQ's, OQ's, and PQ's are in compliance with cGMP's (21 CFR Part 210/211).
  • Developed and executed the IQ, OQ, PQ for Waters Empower Software, CDMS & CTMS applications
  • Well demonstrated expertise in implementing prospective and retrospective validation systems in compliance with 21 CFR11 and 21 CFR 820.
  • Ensured that the documentation adhered to the Confidential Regulatory Requirements.
  • Involved in validation of EDMS (Electronic document management system) which is used to track, manage and store documents in compliance with cGMP, Confidential norms and 21CFRpart11.
  • Excellent working knowledge in Track wise (CAPA), Information Request Management System (IRMS), Electronic Document Management System (EDMS), Inventory management system (IMS)

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