Andrew D. Ezekiel, D.Eng. M. Eng., CSSBB.

**** ******** **. ********* ** 21804

United States of America

ad45bm@r.postjobfree.com

Tel: 443-***-**** (C)

CAREER SUMMARY

Over Twenty years of diversified career in the field of engineering (pharmaceutical engineering), medical devices, diagnostics, manufacturing/production engineering, verification and validation engineering, reliability, human factors and usability engineering, and quality assurance/quality control circles. As a Certified Quality Engineer/Six Sigma Black Belt Practitioner, I implement the principles, practices, and techniques of six-sigma concepts and lean manufacturing to reduce waste, improve processes (continuous process improvement) and reduce cost.

CERTIFICATION

Certified Quality Engineer (June 1997)

Affiliation: American Society for Quality.

Certified Six Sigma Black Belt (October 2006)

Affiliation: American Society for Quality

EDUCATION

Bachelor of Science: Industrial Mathematics, University of Benin, Nigeria, September 1987.

Master of Engineering: Industrial Engineering, Morgan State University, Baltimore. MD., USA.

May 2001.

Doctor of Engineering: Industrial Engineering, Morgan State University, Baltimore. MD., USA.

May 2006.

Presently, I have completed 15 credits towards the Doctoral Degree in Mechanical Engineering, University of Maryland, Baltimore. MD. USA.

I attend the Annual Statistical Issues for Medical Devices and Diagnostics sponsored by FDA (Food Drug Administration).

TECHNICAL KNOWLEDGE

_Good manufacturing/production practices. Ensure compliance to standards (Standard

Operating Procedures (SOP), Common Good Manufacturing Practices (cGMP) & ISO

Standards)/Specifications prior to release of in-process and finished product.

_Good laboratory practices, applies laboratory techniques, instrumentation, Geometric

dimensions and tolerances (GD&T), Gage R & R, metrology, mechanical testing

(Reference standards, calibration), and documentation to ensure the validity of data and

test results.

_ Develop statistical analysis plan/Sample size determination for clinical studies, and migration

studies.

_ Experience with various manufacturing methods such as compounding, filling process,

injection molding, machining and metal stamping.

_Perform statistical analysis using JUMP, SAS, and MINITAB Software.

_Design of experiment (DOE). Use statistical, numerical and matrix analysis approach to

solve multivariable and complex industrial problems.

_Facilities/critical plant systems: Implements Installation, Operational and Performance

qualifications protocols to new and modified facilities/systems.

_Application of latest instruments, automation, robotics and quality tools (robust

design & statistical process control) to solve complex industrial problems.

_Develop and perform system reliability analyses and process improvement activities.

_Good knowledge of FDA 21 CFR Part 4, 210, 211, & 820.30, ISO 9001& AS9102, ISO 14971 & ISO 13485, IEC60601, IEC62304 and EU Medical Device Directives. Production Part Approval Process (PPAP). Root Cause Corrective Action (RCCA).

STRENGTHS

_ Excellent industrial problems and analytical solving skills.

_ Versatile and professional in appearance.

_ Experience in Aseptic manufacturing and sterile injectable.

_Work effectively as a team player.

_ Able to work effectively with little or no direction

_ Able to prioritize multiple responsibilities and work on multiple projects simultaneously.

_ Excellent verbal and written communications skills and ability to effectively

communicate across multiple levels of an organization.

_ Very detail oriented.

_ Strong research skills

_ Excellent technical writing skills

_ Excellent editing and proofreading skills.

_ Advanced knowledge of statistical methodology

_ Good understanding of machining, welding, assembly operations, gauging, SPC, APQP,

and quality assurance systems (ISO 9001, AS9100).

_ Well versed with Risk Assessments, Hazard Analysis and Design Controls.

_ Full knowledge and understanding of policies, procedures, and guidelines relevant in the

development of documentation.

_ Able to work in a team environment, including inter-departmental teams and key contact

representing the organization on projects.

_ Have a strong background in Quality Management Systems.

EMPLOYMENT HISTORY

Sr. Quality Engineer

Infortree Inc.

EATON CORPORATION (Through Infortree Inc. Agency)

11642 Old Baltimore Pike,

Beltsville MD 20705

27 November 2023 – 09 February 2024

Responsibility

Current focus on the creation and completion of First Article Inspection Reports (FAIR), per AS9102, Rev. C

Create FAI (First Article Inspection) Inspection Plans for Inspectors to complete, as part of the verification process

Compile relevant documentation, ensure all operations have been completed and signed-off.

Communicate with various levels of Operations to push assembly and testing Router operations to completion.

Periodically, witness factory testing for verification of activities.

Review all Vendor certifications and Inspection Plans for compliance against Internal, also Customer drawing requirements.

Route completed FAIRS to Management for final review and acceptance signatures.

Investigation Writer

Emergent BioSolutions Inc.

1000 Paca Street.

Baltimore.

18 October 2021 – 19 May 2023

Responsibility

Wrote investigations reports (Engineering, Equipment, Manufacturing, Automation, Inspection & Packaging, Microbiology lab, QC lab and related deviations)

Initiated/wrote deviation/Investigation reports from start to finish using Veeva Software.

Conducted Root Cause Analysis (RCA)/CAPA) and wrote investigation reports.

Interface with multiple different groups.

Completed Investigation for bulk drug manufacturing equipment.

Lead Sustaining Engineer

EASi LLC Inc.

7077 Bonneval Road,

Suite 500

Jacksonville, FL 32216

July 01, 2019 – September 13, 2020

Responsibility

Remediation of Arthrex (Implant Manufacturing Company) Design History File

Performed Assessments for the Design of Medical devices/Gap analysis.

Performed Traceability matrix

Performed risk analysis, use failure mode and effect analysis (uFMEA), and design failure mode and effect analysis (dFMEA)

Wrote investigation / summary reports

Quality Engineer

Personal Genome Diagnostics Inc.

3600 Boston Street, Baltimore, MD21224

March 05, 2018 to December 18, 2018

Responsibility

Provided technical assistance and expertise in the development of PGDx’s quality management system documentation to support the company’s IVD products.

Wrote, edited, and maintained Quality System’s procedures and work instructions.

Developed Master Validation for the company.

Provided technical input and expertise to ensure the Validation / design transfer and process validation activities are adequate to transfer IVD products to Operations.

Supported the investigation of quality events such as nonconformities, CAPA’s, customer complaints, and product corrections and removals.

Supported the development of process monitoring and measurement utilizing statistical tools as applicable.

Provided support and assistance during regulatory authority audits, as appropriate and as directed by the supervisor and the Management Representative.

Assisted with the preparation of regulatory submissions related to changes to on-market IVD devices.

Reviewed and approved IQ, OQ and PQ, final validation reports and deviations for validation protocols.

Senior Validation Engineer (Medical Engineering Department)

Canon Virginia Inc.

Newport News, VA23606

August 04, 2014 to March 03, 2018

Responsibility

As the Leader of a cross-functional team (Engineering, Marketing, Quality Assurance, R & D and Compliance) we implemented FDA Design Control Concept, Human Factors/Usability Engineering in the planning, Design and Development phase, up to the design transfer phase for Canon’s Medical device DNA Analyzer.

Scheduled, plan, author, and execute as needed verification, validation and test protocols and reports to support product commercialization and manufacturing of an automated genetic analyzer for In Vitro Diagnostic (IVD) use (hardware, software, assay chemistry) according to schedule.

Reviewed and approved validation project documentation.

Reviewed and approve Engineering drawings.

Implemented Design Control phases, from the design and development planning phase through the verification and validation phases to the design transfer and design history file (DHF) phase.

Coordinated and interfaced with R&D (Assay and Instrument), QC lab, Engineering, and Software development (IT), Marketing, Manufacturing and Quality Assurance groups to assure successful project execution.

Provided Quality oversight for validation deviation investigations to resolve execution or result discrepancies and participate in the resolution of deviations and corrective/preventive actions.

Provided Quality review and assessment of associated change requests related to processes, equipment, material, facilities, software, and computer systems.

Analyzed data and report trends in manufacturing and quality.

Supported the development of best demonstrated validation practices in the validation department, based on current industry practices and guidelines and in accordance with appropriate regulatory agency validation requirements (GAMP, FDA, ISO, IEC, EU, and Health Canada).

Authored, assigned Standard Operating Procedures (SOPs) to ensure compliance with Company policies and federal regulations.

I oversee risk management activities (dFMEA, uFMEA and pFMEA).

Provided computer systems validation support for electronic quality management systems, spreadsheets, databases and other systems subject to 21CFR Part 11 requirements.

Managed company-wide equipment calibration program to include oversight of outsourced calibration activities, scheduling, and validation of equipment and systems where applicable.

Participated in risk analysis activities including using risk-based approach in design of validation protocols.

Provided training and guidance to other departments concerning validation requirements and protocol execution.

Performed other duties as assigned by R & D Director and QA Director.

Senior Quality Engineer

QIAGEN INC

Gaithersburg, Maryland 20878

(January 8, 2007 – February 19, 2013)

Responsibilities.

Developed, Implemented and Monitor Quality Systems in support of Food and Drug Administration (FDA) Compliance regulations and International Organization Standards (ISO 13485 for medical devices).

Designed, developed, and applied methods and procedures for testing and evaluating products and/or processes. Performed risk analysis.

Utilized designed of experiment (DOE), capability studies and other statistical tools for continuous process improvement.

Performed Statistical analysis for R & D, and Compliance departments. e.g., reviewed and analyzed clinical data, QC data and migration data, etc.

Reviewed/Rewrite/Approve Packaging, Manufacturing, and Quality Assurance SOP’s

Used Failure Mode and Effect Analysis (FMEA) and Fault Tree Analysis (FTA) to identify all possible failures in designs, manufacturing processes, products and services

Implemented Risk Management activities for new and modified products.

Designed and evaluated attribute sampling plans, and acceptance criteria for incoming materials and finished products.

Design Control (Verification & Validation of each phase). Supported process validation, IQ, OQ & PQ, and utility systems (Purified water system, WFI, CIP & HVAC). Cleaning verification and new product development to ensure products meet customer requirements.

Analyzed clinical data for management.

Performed statistical analysis of historical data to determine appropriate sample size for verification, and validation of clinical, non-clinical and migration studies.

Trained employees on six sigma concepts, problem-solving techniques, process improvement and root cause analysis.

Implemented 5S Lean program in Manufacturing and Ware house departments to reduce and eliminate wastes. Developed process map for manufacturing and ware house department.

Developed and implemented statistical process control (control charts) for process and product trending, deviation trending.

Senior Quality Engineer/Senior Production Supervisor

Actavis Mid-Atlantic LLC, Former Alpharma, United States Pharmaceuticals Division

7205 Windsor Blvd. Baltimore, MD 21244

(June, 1993 – Jan 5, 2007)

Responsibilities.

Planned and directed activities concerned with development, application, and maintenance of standards for pharmaceutical manufacturing processes, materials, and products.

Supervised Aseptic manufacturing and sterile injectable manufacturing/packaging departments.

Performed risk analysis for new and modified products and processes which include risk assessment that occurs in the appropriate phase of each project, authorized risk management plans, and reports, facilitated risk assessment activities with no guidance.

Developed process metrics to evaluate process performance for compliant, effectiveness and efficiency.

I actively participated in FDA inspections; both pre-inspection activities and inspection management.

I maintained compliant records, and support regulatory reporting of device incidents and assisted with non-conformity, corrective and preventive action (CAPA) processes per US 21CFR820

I maintained document and change control process and system to assure that all procedures meet regulatory, company, and customer requirements.

Review documents e.g., batch records, IQ, OQ & PQ protocols for style, clarity, grammar, and punctuation

Developed/implemented, and trained QA Inspectors on AQL attribute sampling plans for

incoming materials, in-process and finished goods.

Developed and implemented process improvement activities, statistical process control (SPC) and quality programs/systems.

Provided leadership for compliance with standards, specifications and regulations to facilitate the improvement of processes and product.

Managed/Supervised and implemented manufacturing/packaging operations for new and existing products, Complaint system, QA in-process, Incoming Associates, Quality Engineers and manufacturing Supervisors.

Resolved Customer complaints using 5 whys and six-sigma tools.

Performed investigations and implemented Corrective and Preventive Action (CAPA) per FDA requirements.

Prepared protocols for performance testing, reviewed and implemented verification and validation protocols

Developed, reviewed/approved and implemented Installation Qualifications, Operational Qualifications, and Performance Qualifications for new and existing equipment/machines.

Performed audits (internal and external), supplier qualification, evaluate materials, in-process and finished products, processes, systems, and controls.

Doctoral Research Work

Doctoral Dissertation: Optimization Modeling and Variation Reduction in Pharmaceutical Production Processes by Quality Engineering and Robust Design. It is anticipated that this research work will reduce cost of production by approximately half a million dollars annually.

Publications:

Papers: “Weight-Variation Reduction in a Pharmaceutical Filling Process Through

Parameter Design Aimed for Robustness”, Proceedings of 2001 International

Conference on Engineering Design and Automation, Las Vegas, NE, Aug 5-8,

2001.

“Variation reduction of pharmaceutical filling process by robust design”, Proceedings of seventh ISSAT International Conference on Reliability and Quality in Design, Washington, DC, Aug. 8-10, 2001.

“Economic Design and Development of Optimal Upper Specification Limit for a Filling Operation”, Proceedings of 12th ISSAT International Conference on Reliability and Quality in Design, Chicago, Illinois, Aug. 3-5, 2006.

Mathematics Teacher (Substitute): Chesapeake High School, Baltimore, MD.

Catonsville High School, Baltimore, MD.

(1994 -1996)

Responsibilities

Taught Algebra, Geometry, Calculus, Consumer Mathematics and Trigonometry.

Production Supervisor, Press Shop, Ford Motors Company, London, Britain

(April 1992 - January 1993)

Responsibilities:

Planned and organized the departmental work.

Trained and reviewed employees’ performance appraisal.

Counseled employees and resolved conflict(s).

Senior Mathematics Teacher: Saint Mary’s Grammar School, Eme-ora, Edo State, Nigeria.

(June, 1988 – Dec. 1991)

Responsibilities:

Developed and conducted lectures in Mathematics.

Managed School curriculum. Performed Student-parent counseling duties

Conversant with Microsoft office (Windows, Excel, Power point), AutoCAD, SAS, Minitab, JMP, and SPSS

REFERENCES

Available upon request.

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