SUMMARY:

• Extensive and diversified experience as Validation Engineer in Healthcare/ pharmaceutical industry with compliance to FDA 21 CFR Part 11.
• Experience in Computer System Validation, Medical Device Manufacturing Validation, SPC, Laboratory Instruments/Manufacturing Quality System Validation.
• Expertise in developing and executing Validation Protocols (IQs/OQs/PQs) and construction of Validation Summary Report (VSR).
• Excellent understanding of all GxP regulations (GLP, GMP, GCP).
• Experience in Facilitating the Computer System Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system.
• Expertise in multiple validated electronic systems including Werum MES and LIMS.
• Proficient in dealing with Laboratory information management system (LIMS) and Adverse Event Reporting System (AERS).
• Experienced in initiation of GAP analysis, and developing Remediation Plans to resolve the compliance problems.
• Good understanding of industry standards and FDA regulations.
• Applied knowledge in ISO 13485 Quality Systems, ISO 14971 Risk management to medical devices, FDA Inspection approach (QSIT), IEC standards (IEC 60601, IEC 62304), and FDA medical device regulations (21CFR820).
• Performing GAP analysis to check compatibility of existing system infra - structure with new business requirements.
• Well versed in performing Root Cause Analysis and suggesting corrective actions.
• Communicating complex business solutions to all levels of project team.

TECHNICAL SKILLS:

Life Sciences: FDA, quality system regulation, 21 CFR part 11, 210, 211, 820, cGxP, GAMP, IQs, OQs, SOP’s, LIMS, AERS, summary reports and Audit Trails.

Work flow tools: MS Visio.

Testing tools: Quality center, QTP, Load Runner.

Management tools: Rational Requisite Pro.

Microsoft tools: MS word, MS PowerPoint, MS excel and MS access.

Database tools: SQL, MS access, oracle.

Operating system: Windows 98/2000/XP/vista/7.

PROFESSIONAL EXPERIENCE:

Confidential, Morrisville, NC

Quality Validation Engineer

Responsibilities:

• Performed execution of validation protocols for manufacturing equipment.
• Write user requirements, IOQ protocols and validation final reports for various automation software and manufacturing equipment.
• Followed the SDLC in all stages of the project to develop validation deliverables including Validation Plan and Validation Summary Report.
• Establish risk analysis, software requirements specifications, and validation protocol for manufacturing equipment database.
• Participated in execution of cleaning validation test protocols. Performed manufacturing batches, generated electronic Batch Records.
• Create IQ, OQ, and PQ Test Scripts.
• Develop validation documentation as required (such as specifications, plans, protocols, and procedures) in line with current industry best practice and risk based approaches for software associated with a variety of manufacturing equipment for class I and class II medical device manufacturing, including COTS and in-house developed software.
• Create assessment documentation to determine if software is GxP, GAMP 5, and/or 21 CFR Part 11 relevant.
• Execute qualification protocols as required and coordinate qualification activities in line with the project schedule.
• Prepare reports of executed protocols for review by QA.
• Coordinate qualification document review and approval.

Confidential, Branchburg, NJ

Validation Engineer

Responsibilities:

• Project was to maintain, document and improve quality compliance and standards of products throughout the manufacturing line in adherence to FDA regulations and author cleaning validation plans, protocols and reports for various equipment - process & laboratory.
• Collaborated with manufacturing and quality departments to improve full life cycle validation
• Created and executed validation of analytical instruments
• Assessed existing manufacturing processes for a range of products and identified improvement for implementation with guidance from manager and senior engineers
• Executed a Complaint Handling/Regulatory reporting to effectively implement a global and consolidated approach to manage customer complaint and medical device reporting
• Efficiently utilized document management best practices and followed GxP and GAMP compliance within a regulated environment
• Generated decommissioning documentation corresponding to each Manufacturing equipment and Utilities included in the Decommissioning plan, as well as coordinate and supervise the End-of-Use Calibration efforts to be performed on all systems to be decommissioned.
• Reviewed Operational Qualification protocol for equipment related SOP and functional specification verification
• Executed equipment validation protocols, reviewed data and prepared validation summary report

Confidential, Waukegan, IL

Validation Engineer

Responsibilities:

• Performed validation of computerized system in support of a software upgrade.
• Worked on implementing tracking of requalification activities using existing GXP software; included developing and giving training program to validation staff.
• Involved in recommissioning of cGMP facility.
• Responsible for maintaining the cleaning validation program during a manufacturing campaign; responsible for tracking cleaning validation activities and interacting with manufacturing personnel to ensure accurate and timely results.
• Assisted in the execution of OQ/PQ on various types of equipment.
• Authored and executed IQ/OQ/PQ protocols for manufacturing equipment followed by summary report writing.
• Review and approval of equipment / process validation protocols and summary report.