Sr Validation Engineer Resume
Bloomington, IN
SUMMARY
- Professional experience in IT industry with expertise in validation of documents and equipment used in manufacturing and other aspects of Computer Systems Validation.
- Professional Profile: Working experience in FDA regulated environment and pharmaceutical companies with good understanding of cGxP (cGMP, GDP, cGLP) standards and Risk based validation.
- Experience in Pharmaceutical Environment with expertise in Computer System Validation (CSV), Equipment Validation, Technical Writing, Validation Testing and with strict adherence to GAMP & cGMP regulations
- Superior knowledge of GAMP, GxP's (GCP, GLP and GMP), 21 - CFR Part 11 regulation of Electronic Records, Electronic Signatures and Audit Trails.
- Hands on experience in projects involving Validation Master Plan (VMP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).
- Hands on experience in DFMEA and PFMEA Analysis.
- Understanding of GXP standards, 21 CFR Part 11, Part 210, Part 211, Part 820, ISO 13485 & 14971 and Audit Trials.
- Good knowledge of design and Validation of the Packaging of sterile and non-sterile medical devices
- Experience in Statistical Process Control (SPC) Methodologies and best practices.
- Thorough experience FMEA, Root Cause Analysis, and Statistical Process Control (SPC)
- Experience in Design of Experiments (DOE) and Design History Files (DHF). knowledgeable/experience, SPC, GD&T, Process control plan, Design of Experiment, Layout inspection techniques, Lean Manufacturing, Gage R&R, DMI/DFA, PFMEA, CAPA, Capability study, Process flow diagrams, root cause analysis, corrective action, value stream mapping.
- Expertise in Process Validation, Test Method Validation, Design Control Activities, worked on end of life change controls, DHF Remediation.
- Strong skills with Risk Assessment, Corrective Action and Preventive Action (CAPA) investigation.
- Expertise in Software Development Life Cycle (SDLC), familiar with Waterfall, V-shape model and agile model.
- Good experience in preparing Computer System Validation Plan (CSVP)
- Skilled in developing Standard Operating Procedures (SOP's), policies and working instructions to comply with FDA regulations.
TECHNICAL SKILLS
Compliance: 21 CFR Part (11, 210, 211, 820, 56, 50), GAMP, cGMP, GxP (GDP, GMP, GLP, GCP), QSR, ICH Guidelines.
Business Tools: MS Office, Acrobat, MS VISIO, Share Point.
Computer System Validation: SOP’S, VMP, URS, FRS, DS, Test protocols and Summary Reports, RTM and VSR, Risk Assessment Techniques.
Methodologies: Software Development Life Cycle (SDLC), Validation Life cycle (VLC), Testing Life Cycle(TLC)
Other Tools: AutoCAD, Unigraphics NX, Teamcenter, Matlab, Maple, MS-Office, CAN Communication, Motohawk Tools, Technical Writing, Medical device Design control, GD&T, Tolerance Stack up analysis, Blue print reading Medical
Device Validation: CFR Part 820, QSR, ISO 13485
Validation Applications: UDI, MDM, LIMS, EDMS, AERS
PROFESSIONAL EXPERIENCE
Confidential - Bloomington, IN
Sr Validation Engineer
Responsibilities:
- Prepared and reviewed Validation Master Plan (VMP) and Validation Summary Report (VSR).
- Followed SDLC Methodologies and industry standard practices to Validate Computer Systems.
- Gathered business requirements from end users.
- Gathered and documented User Requirements Specifications (URS) for various systems.
- Gathered, analyzed and created Functional Requirements Specifications (FRS).
- Developed and maintained the Requirements Traceability Matrix (RTM) in support of Validation.
- 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.
- Performed DFMEA and PFMEA Analysis. Performed GAP Analysis of existing RM Plans and suggested Remediation activities. Created Design History Files.
- Performed Regulatory Assessment and Risk Assessment for the Computer Systems.
- Performed GAP analysis, developed Remediation plans.
- Analyzed product and process failures to ensure effective root cause analysis and implementation of corrective and preventive actions (CAPA) for internal and external customers
- Improved robustness of PPAP, pFMEA, Control Plan quality processes across the plant
- Wrote and executed Operational Qualifications (OQ) and Performance Qualifications (PQ) Protocols.
- Used ProcessComplianceto create Corrective Actions, and events.
- Worked on root cause investigations and CAPA (Corrective And Preventive Action) activities
- Analyzed system requirements and developed Test Plans, Test Scripts.
- Responsible for performing User Acceptance Testing (UAT) for the application.
- Followed Good Documentation Practices (GDP's) to record and report test results.
- Involved in periodic auditing of the change management systems to ensure that the change management systems are in compliance with SOP.
Confidential - Plainsboro, NJ
Validation Engineer
Responsibilities:
- Involved in validation of LIMS implementation and QMS (TrackWise) upgrade of Web based applications in accordance with Company policies and procedures.
- Reviewed the user requirements document and prepared the detailed Test Plan and Test Criteria for validation of CAPA module and Supplier Quality Management System (TrackWise).
- Worked with multiple business departments and updated the User Requirements for various document management work flows.
- Interacted with IT department while building servers and databases for LIMS and TrackWise applications.
- Setup Active Directory accounts for users of LIMS and TrackWise based on specific roles in system.
- Developed ITIL processes for hardware and software components of application in compliance with FDA.
- Worked with the business/technical teams and updated the Functional Requirement specifications.
- Provides required inputs to teams and handled all project activities to accomplish project deadlines
- Authored Risk Management Plans, URS, FRS, IQ, OQ, Validation Master Plan, Test Plan, Validation Summary Report, Requirement Traceability Matrix, Test Reports, System Investigation Requests, UAT Designs, Technical Design document, UAT report and other validation deliverable as deemed necessary for the validation effort.
- Involved in modelling of work flows using LIMS system, creating samples and tests, entering results, checked the results against specifications and set up approval steps.
- Demonstrated the configured Interface aspects to the End Users, business and Quality Teams
- Provided to the UAT testers and maintained their records.
- Authored 21 CFR Part 11 Assessment for various Lab Instruments to handle the record maintenance, audit trail activities for FDA Audits.
- Reported the Validation progress to the Quality director on a weekly basis.
- Provided Quality and Compliance oversight for GxP systems and reviewed all the Validation deliverables
- Authored Test Scripts for Quality Management System (TrackWise Change Control and LIR Protocol Modules)
- Reviewed the developed SOPs for Change Control and Security for LIMS.
- Worked closely with Development team to identify and create the test scenarios and test cases, the test cases included Unit testing of Individual document management work flows.
- Prepared Deviation Reports, Deviation Logs for the various errors occurred during the test execution.
- Prepared 21 CFR part 11 and GxP assessment checklists for electronic records and electronic signatures to verify Audit Trail, Security, and Authority Checks.
- Secured, consolidated and archived executed change controls and records of validation team members as part of record management.
Confidential, Tarrytown, NY
Validation Analyst/Engineer
Responsibilities:
- Created the Data migration plan, and performed data mapping of source and target fields.
- Developed Crystal Report templates for Trackwise and single/multiple reports for adverse effects.
- Conducted requirement analysis and design walkthroughs sessions with the developers, business users and management staff.
- Responsible for cGMP Systems Validation, Computer and Software Systems Validation Compliance with 21 CFR part 11, FDA Audit, IQ, OQ, PQ Traceability Matrices.
- Plan and coordinate validation and testing with manufacturing engineers, and process supervisors.
- Prepared Requirement and Functional Specification and Trace Matrix documents.
- Prepared Dashboard to keep Trackwise of the test activities.
- Hands on experience in formulating Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) for validating.
- Manage deviations/non-conformances to ensure timely investigation, root cause analysis and implementation of corrective and preventive actions (CAPA).
- Generated Validation Summary Report to summarize and document all validation activities
- Developed and reviewed Standard Operating Procedures (SOPs) for various functionalities of the system.
- Responsible for coordinating, locating, tracking, organizing, and verifying validation documentation for cGMP compliance and regulatory requirements.
- Develop Risk Assessments using FMEA to identify possible risks associate to the product.
- Responsible for coordinating, locating, tracking, organizing, and verifying validation documentation for cGMP compliance and regulatory requirements.
- Reviewed the User Requirement and prepared the detailed Test Plans and Test Criteria.
- Developed, reviewed and executed Test Plans, Test Cases and Test Conditions.
Confidential - Noblesville, IN
QA/Validation Engineer
Responsibilities:
- Developed supplier validation processes, including MVP, IQ, OQ, PQ processes to meet FDA regulations.
- Managed complaint investigations and determined if a CAPA or MDR was required, including failure analysis and root cause investigation, and generating detailed customer closure reports.
- Responsibilities include providing support to the regulatory department for remediation. Actively coordinating various functions across multiple departments to initiate and drive progress of Product, Process, and Consent Decree Work Stream CAPAs.
- Participated in design reviews, design transfers, and in all aspects of the Design Control and risk management processes.
- Lead in the development, evaluation and execution of Test Method Validations (TMVs) which require the usage of statistical tools such as ANOVA.
- Managed Supplier Compliance activities for vendors assessing the supplier capabilities of meeting manufacturing and regulatory standards including ISO, FDA, and CGMP.
- Supervised IQ, OQ, PQ's, and process validations of all new Packaging Equipment.
- Developed OQ Summary Report, PQ Summary Report and Validation Summary Report summarizing the validation activities and Deviations resulted from OQ/PQ Execution.
- Created Verification and Validation SOP and other templates for Remediation.
- Performed Quality review for validation lifecycle documentation for various medical device product families, including: Master Validation Plan, Formal Test Plan, DOE, Process Validation, Test Method Validation, Installation/Operational/Performance Qualifications, and Summary Reports
- Used Agile PLM to manage the life cycle of all the Validation documentation. Facilitate Annual Risk Review and Risk Benefit Analysis, update Risk Assessment and Control Table, DHF, and Change Control documentation.
- Supported quality cross functionally working with resources in Incoming Quality, Materials Management, Purchasing, and Quality Management to resolve supplier quality issues.
- Experience with test protocol documentation, Design Reviews, and the complete NPD process.