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KAYLA  NIJMEH

309 S. Harlem

Chicago Ridge IL, 60001

Tel: 708-323-9876

Kayla@yahoo.com

SUMMARY

•·      11 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation.

•·      Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports.

•·      Experience in Manufacturing Process, Quality Control, and Process Control

•·      Experience in FDA Quality System Regulation, IQ/OQ/PQ, FDA Compliance, cGMP Audits, MPR's, SOP's, 21 CFR Part 11, 211, and 820

•·       Audit Validation for Process Validation and manufacturing  activities against FDA compliance and 21CFR part 820.

WORK EXPERIENCE:

Jan.10 - Present Stryker Instruments, Kalamazoo, MI -Process Auditor.

•·      Audited suppliers for process validation and manufacturing process, per FDA regulations, 21 CFR part 820, and Stryker requirements.

•·      Assisted suppliers on remediation projects, including process development and validation requirements.

•·      Prototype development for Stryker S7 Handpiece Generated and executed DOE's, OQ/PQ, and  IQed all required equipments.

•·      Completed Computer System Validation documentation improvement as part of internal audit readiness project.

May. 09-Jan-10              Boston Scientific, (Neuromodulation)  Valencia, CA, - Validation Engineer.

•·      Generated and executed Installation Qualification Protocols (IQ) for various medical devices, equipments such as Pull Tester, Soldering machines, Sealers, and Refrigerators.

•·      Generated and reviewed validation principles including user requirements, functional specifications, and IQ, OQ, PQ as part of process validation for Implant Pulse Generator (IPG) medical device.

•·      Temperature mapping for medical device equipment such as, Coolers, Sealers, Ovens

•·      Performed Quality review for validation lifecycle documentation for various medical devices, including Installation/Operational/Performance Qualification and summary report

Oct. 08- Apr.09 Boston Scientific, San Jose, CA, - Validation Engineer, (Team Lead).

•·      Generated and executed Test Method Validation (TMV) Protocols for  various medical devices, product such as SteeroCath Dx, Chilli II, Blazer II, and Polaris X.

•·      Analyzed statistical data, product and specifications to resolved nonconforming issues and wrote NCR reports and determining 21 CFR Part 11 applicability and compliance.

•·      Remediation Activities including writing Gap Analysis ,Validation Master Planes, Risk Assessment; associating with system redesign; Performance product Validation Protocols and writing final reports.

•·      Performs validation activities which include defining test protocols, executing test protocols, trained manufacturing personnel on validation documents and Interacts with all personnel involved in the execution of protocols and final reports.

Jul. 07- June-08 Boston Scientific, Fremont, CA - Process Development Engineer.

•·      Generated and executed OQ/PQ protocols for medial devices processes as Atlantis PV Catheter (Imaging Catheter), and generated final/summary reports.

•·      Analyzed statistical data, product and specifications to resolved nonconforming issues and wrote NCR reports and determining 21 CFR Part 11 applicability and compliance.

•·       

•·      Developed process performance throughout process, created process fixture and tooling to facilitate production, and reviews validation documents including Master Validation Plan and System Specifications.

•·      Trained manufacturing personnel on validation documents and Interacts with all personnel involved in the execution of protocols and gathering of test data. Gathered and recorded all data in accordance with GxP requirements.

•·      Performed Quality review for validation lifecycle documentation for various medical devices, including Installation/Operational/Performance Qualification and summary report

Jul. 06- Jun. 07  Boston Scientific, IN - Validation Engineer, Medical Device Comp., (Team Lead)

•·      Performed Gap Analysis and Remediation activities for of medical device, including determining 21 CFR Part 11 applicability and compliance.

•·      Remediation Activities including writing Validation Master Planes, Risk Assessment; associating with system redesign; Performance product Validation Protocols and writing final reports.

•·      Trained Manufacturing Personnel on various process validation documentation.

•·      Generated and executed IQ/OQ/PQ protocols for medical devices processes such as Grieve Oven, Tipping Machine, Laser Mike, Laser Welder, Molding Machine, and Cut Length machine, Drainage Catheter, Extrusions, and wrote final/summary reports.

•·      Performed Quality review for validation lifecycle documentation for various medical devices, including Installation/Operational/Performance Qualification and summary report

May 05-Feb. 06  Eli Lilly and Company Indianapolis, IN  -  (Validation Eng.)

•·      Developed and executed IQ, OQ Protocols for HVAC systems, start-up and Commissioning documents of HVAC

•·      Developed and executed Particulate recovery testing for new process building.

•·      Prepared final reports.

•·      Performed an IQ, studies for variable equipments such as fill lines, cappers, tanks, and receivers involving PLCs and HMIs.

Feb.04-Feb. 05   Abbott Laboratories, Abbott Diagnostic Division (ADD), Abbott Park, IL

Validation Engineer

•·      Reviewed Manufacturing Document and Operating Procedures for compliance with Test Method Validation Packages.

•·      Developed and Reviewed validation Protocols and SOP's for variable instrument's such as IMx, AxSYM, ARCHETECT.

•·      Generated, reviewed, and executed validation protocols, reports, and SOP's; provided inputs on updates to Validation Plans and helped resolving issues.

•·      Performed Gap Analysis and Remediation Activities for a variety of instruments, including determining 21 CFR Part 11 applicability, and compliance, determining completeness of qualification and validation testing.

Oct.01-Dec.03            Aventis Behring Biopharmaceuticals, Kankakee, IL -Validation Eng. (Team Lead)

                                Process validation

•·      Developed, executed process validation protocols for Biologics such as IEC, HIC.

•·      Performed statistical analysis on product laboratory results in order to determine product uniformity and product reproducibility.

•·      Managed the execution of validation protocols, evaluate validation results, and complete projects in timely manner.

Facilities validation

•·      Validated HVAC Systems: Clean room classification, Aseptic area, and facility qualification including particulate testing and unit operation testing.

•·       Developed and executed protocols for WFI, Pure Steam Systems, and  HVAC commissioning documents for distribution center, utilities, facilities and provided feedback with the corrective action plans for resolving short and long term deficiencies.  

•·      Resolved issues and wrote the final reports.

Equipment validation

•·      Developed and executed IQ, OQ and PQ protocols for a variety of equipments such as fill lines, cappers, tanks, and receivers.

•·      Developed Detailed Specification documents for automated manufacturing and packaging equipment.

Cleaning & Hold time Protocols

•·      Executed cleaning validation protocols for a variety of equipment.

•·      Wrote and executed process validation hold times studies..

                                Aseptic Area certified for 2 years.

                               

Jan.00-Aug.001          AT&T Project, Chantilly, VA - Field Test Engineer

•·      Gathering data for different wireless network, which describe each network performance generically in terms of received signals strength, quality, voice quality, along with the locations and statistics with blocked, dropped calls and handover.

•·      Troubleshooting software/hardware for benchmarks, wireless phones.

•·      Supporting multi wireless technology such as GSM and CDMA

May.97-Mar.00           United parcel services (UPS)  - Technical Support Technician

                   Support multi operating system using DOS, Win 3.1, win95, win98, winNT, OS2

•·      Troubleshooting hardware and software such as (system units, printers, monitors, scanners and laptops).

•·      Assist users to resolve computer related problems such as inoperative hardware or software.

•·      Trouble shoots software, hardware and connectivity issues

EDUCATION:

2007                Completing Master of Science in Management Business Adm. (MBA)

                        (Governor State University - Illinois)

2007                Minitab Statistical Analysis (Boston Scientific)

1999                     A+ Certification

1999                Completed M.C.P (Microsoft Certified Professional)

1993                BS in Economics & Statistics (University of Jordan - Jordan)

TRAINING    FDA Quality System Regulation, IQ/OQ/PQ, FDA Compliance, GxP Audits, MPR's, SOP's, 21 CFR Part 11, PVR., Minitab.

SKILLS    Windows XP, 2000, 98, and MS office : Excel, Word, Outlook, PowerPoint, Access, Visio, MiniTab Statistical.

Familiar with LAN, WAN, Trackwise, Windchill, PDM, Kay Validator quiepment.

Strong interpersonal, technical writing, organizational skills.

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