SUMMARY:

• Innovative, results - driven engineering professional with extensive hands-on experience in the fields’ of software / equipment and computerized systems / control systems validations.
• Systems development and validation using SDLC life cycle methodology and GAMP 5.
• Extensive design engineering experience with Automation and BMS/HAVC validation. Medical Device / Pharmaceuticals and Bio-Tech Industries.
• Software Validation and compliance to 21 CFR Part 11, ERES, and GAMP 5.
• Equipment Commissioning and Validation - Sorting and Packaging Equipment, Cold Rooms, Temperature controlled rooms, Cryo Freezers, Chromatography Skids, Nitrogen System, Bio-Reactors and plastic injection molding for drug bags.
• Software Quality Engineer working with Validation Engineers to complete the validation documents and review and sign the IQ, OQ, PQ Protocols and Reports.
• Confidential Software / Hardware Validation.
• Use SDLC methodology for Risk based approach to software validation.
• Computerized Systems Validations
• HVAC Validation for Medical Device
• Confidential Validation Project Management, regulatory configuration and graphical design, FAT and Batch Testing.
• ERP System Validation
• P&ID preparation and instrument mark-up according to client specifications and requirements.
• Annual Sterilizer validation cycle.
• Packaging and sorting line validation.
• Design of startup/shutdown logic for boiler fireside, using Triconex PLC system.
• Working knowledge of GAMP5, 21 CFR part 210 and 211, and 21 CFR Part 11, ERES, 21 CFR part 820, ANSI/AAMI/IEC 62304 Medical Device Software and System Development Life Cycle Process.

KEY COMPETENCIES:

• Software Validation. 21 CFR Part 11, ERES
• Equipment SOP and Validation - Consulting
• Instrumentation Validation
• Gas Analytical Systems - Consulting
• Software Quality reviews and systems audits
• Software compliance and Gap assessments
• MES Validation (Camstar)
• HVAC and Controls validation
• Confidential Validation and Project Management
• Software Quality Assurance - Consulting
• QMS Implementation - Consulting
• Risk Management
• GxP Standards and Compliance (GAMP5)
• Quality Systems Regulations (FDA)
• Failure Modes Analysis (FMEA Design-Process)
• Design/Process Risk Analysis ( Confidential & Confidential )
• Personnel Management
• Equipment and Process Validations
• Trained on Confidential Implementation and Batch Programming in Austin Texas Facility.
• Data Migration Plan - Development
• Design - Control Systems

EXPERIENCE:

Confidential

Project Manager

Responsibilities:

• Planning validation of Process Control Systems and reviewing protocols produced according to the developed plans.
• Objective is to provide software quality oversite to the process control group.
• Prepare all validation documentation for Confidential 3 Chromatography Data System, and NuGenesis systems.
• Prepared the URS and Validation plan for the Select Agent project, to satisfy the requirements for Confidential .
• Validation of IT Infrastructure, writing URS / FS / IQ and OQ/PQ, plus the validation summary report.

Confidential, Atlanta, GA

Senior Project manager / Validation Engineer

Responsibilities:

• Performed FAT for clients in the Life Science Industry.
• Wrote the user Requirements Specification and Software Design Specification for a Confidential Project in the Life Science Industry.
• Tested Confidential PLC Communication to Confidential via ProfiBus communication card using Confidential PDPS data converter.
• Completed the FAT tests and remediated the deviations before completing the project.

Confidential

Senior commissioning and validation Engineer

Responsibilities:

• Equipment consisted of Tanks, Mixers, Filtration Unit, Heaters, HVAC, and Reactors.
• Perform CAPA resolution activities.
• Control System Design for the new production facility.
• Equipment/Process validation Engineer in charge of writing IOQ protocols for overwrap machine and executing the process validation for the Titan 70% Dextrose product.
• Gathered the data and together with the senior process engineer calculated the Cpk, and the mean and Standard Deviation.
• Project was executed successfully and product was released to the market after the test passed the microbial study.
• Worked on validation of injection molding machine used to prepare the ports for plastic bags used in dual compartment applications for antibiotic.
• Worked with Trackwise EQMS to record and quality issues and discrepancies during the validation of the 70% Dextrose.
• Lead software validation engineer in charge of updating client validation SOP and identifying gaps against GAMP5 procedures to ensure compliance to FDA’s 21 CFR parts 11, and 820.70 for non-product software used in manufacturing.
• Developed the master validation plan and prepared IQ, OQ, and PQ for the site PRMS ERP system, the site OnBase document management system, and validation of the Network with validation of the secured network drives.
• Prepare a Master Plan for Automation Systems Life Cycle Documentation. Identify systems requiring remediation or documents to fulfil Life Cycle Documents from an Engineering standpoint.
• These included Functional Specifications, Hardware/Software Design Specifications, and updating the URS to an acceptable level.
• Was able to complete a set of templates for preparing the FDA requirements as part of software SDLC lifecycle.
• Prepare the Operational Qualification for Confidential System, and execute the OQ as part of Validation of the Confidential System.
• Prepare and Execute the PQ for the Camstar System.
• Completed the OQ validation on time and under budget.
• Use Trackwise EQMS to track the deviations and record quality issues.

Confidential, Irvine, CA

Senior Product software Risk Management Engineer

Responsibilities:

• Reviewed existing Confidential and Confidential Studies and preparing gap analysis documents, HHL, and SHUMA documents in support of Design Quality department.
• Reviewed the DHF, DMR, and the DHR for EvoTech Product.
• Performed gap remediation from existing Confidential and Confidential studies.
• Completed the HHL and SHUMA for product software.
• Document the findings by using TrackWise Application.

Confidential

Senior Software Test Engineer

Responsibilities:

• Performing software testing for Confidential ’s Confidential Batch software.
• Testing phases, operations, unit procedures and procedures.
• Also performing parameter testing, and sequence testing.
• Reporting the software issues through a software test reporting system.
• Completed the validation of the Confidential system for the project per the schedule.

Confidential

Senior Software Quality Engineer

Responsibilities:

• In charge of remediation and validation documents review and adhering to company SOPs and Work Instructions.
• Review the companies QMS for non-product software.
• Prepare a list of gaps and update the document.
• Preparation of IU, and approval of the SDLC documents such as FRS, SDS, and IQ, OQ, PQ, TM, and VSR.
• Worked to have the consent decree removed from company for non-product software.
• Work with response team to Consent Decree audit review.
• Involved with Quality Audits and worked with Management to update the SOPs.
• Worked on all FDA and Regulatory comments in order to bring system up to acceptable standards.
• In charge of writing the first draft of the URS for the JD Edwards ERP system and reviewing protocols for SQAE approvals.
• As a result of my efforts, as SQA, Terumo passed the audit of the third party for FDA submission and approval.
• Perform internal audits to ensure the SOPs are followed and quality systems are in place.
• Updated the TrackWise database with CAPA information and EMDR information regarding the Medical Device complaints handling and Medical Device Reporting to the FDA.
• Perfotm equipment and process validations on manufacturing production lines.

Confidential

Software Validation Engineer

Responsibilities:

• Preparing software design specification documents for customer operating within the FDA regulation for software validation.
• Documentation of configuration, and testing of the phases configured prior to customer acceptance of Confidential System Bio-reactors.
• Prepare Software Design Specification, and Instance Design Specification for Bio-Tech clients.
• Preparing FAT test procedures for a bioreactor system for customer testing and system checkout.
• Worked on the CIP system FAT designed on a Confidential System.
• Completed the SDS on time per client requirements.
• Also completed the Confidential FAT and readied system for client testing on time.
• Working on Various Projects as lead control system engineer helping junior engineers in their design and implementation efforts.
• Prepared validation documents for HVAC system supplying controlled air flow to GMP manufacturing areas.
• These documents included Project Plan, Hardware IQ, Hardware OQ and PQ. Also reviewed and commented on the Master Plan, URS, and the controls.
• Completed all validation documents on time per the client schedule.

Senior Validation Engineer

Confidential, Irvine, CA

Responsibilities:

• Performed Confidential and IQ/OQ validation for equipment used in an entire line of products for Confidential.
• Wrote the validation master plan for each production line and update the Manufacturing Instructions to match the process followed by the technicians on the floor.
• Wrote TMV validation document for the EKG Noise test process on the production line.
• Prepared a project timeline for upper management to show the completion of the project and the resources required to complete the site’s entire validation activity.
• Prepared spreadsheets for the contractors to show progress on a weekly basis.
• Updated the MS project to show the overall site progress.
• Perform equipment and process validations.

Senior Quality Engineer/Software validation Engineer

Confidential

Responsibilities:

• Assigned to Remediation of custom software applications for a medical device company.
• Wrote the Intended Use Documents and performed assessments of the software validation and remediate the gaps found in the validation.
• This was done as an FDA requirement to satisfy the remaining gaps in the validation of custom software.
• Perform software validation for a medical device company manufacturing catheters in Irvine, CA.
• Wrote the validation plan, user requirements, risk analysis, functional specification, design specification, IQ, OQ, and PQ. Perform deviation handling.
• Assist in SOP writing.
• Completed the SOP for writing the control system validation master plan.
• Developed the data migration plan and performed IQ/OQ for the data migration to new servers.