IFEANYI B. CHUKWUJAMA

*** ******** ******

WEST ROXBURY, MA O2132

Telephone: 857-***-****

E-mail: acsy2t@r.postjobfree.com

SUMMARY: A well-rounded engineer with over ten (10) years of experience in validation, quality systems and Research and Development. Major strengths reside in equipment and control systems qualification (IQ, OQ & PQ), process design and development, process validation, project management, process troubleshooting, and quality system management for compliance to cGMP and ISO 9000 requirements. I am also a prolific writer & expert reviewer, with more than twenty (20) self-published books.

EXPERIENCE:

2015 - Present AMAZON, BOS5 Stoughton, Massachusetts

Works part-time at Amazon Fulfilment Center, handling internet orders

2012 - Present AUTHOR

Have self-published over twenty books on important topics such as The Singleness of God; The Truth; Love; Forgiveness; Marriage; Life transcending Biological Processes; The Importance of Obedience to Authority; The Big Bang; True Evolution of Man, of Plants and of Animals; Overcoming Trials; The Origin & Continuance of Life; The Irreversible Dangers of Misapplied Science; The Continental Divide; The First Rain on the Earth; The Origin of Slavery; The Four Ages of the Earth; The Science of Grace; The Ragging War between the Human Spirit and the Human Mind; The Origin & True Nature of Sex; Diversity as a necessary instrument of progress in Society and as a Deterrent for Rogue Leadership; Creation and the Origin of the Earth and the Universe. These books are currently listed on amazon.com

Continue to write every single day, on whatever topic I receive the inspiration to write about

Continue to operate my online business at reduced rate due to diminished sales and profitability

2002 - 2014 ENTERPRENUER

Set up cosmetics and personal care manufacturing operation for private label products

Established operating methods, quality procedures, change-over procedure and documentation for productions and quality assurance

Qualified and validated the manufacturing operation for Medicated Foot Gel, Hair Shampoo, Hair Conditioner, Facial Toning Cream, Body Cream, Hand soaps, Bathroom Cleaner, All-purpose Cleaner, Kitchen Cleaner, Dish Detergent

Manufactured and distributed personal care products and cosmetics to stores and wholesalers

Managed an online business on amazon.com and ebay.com with reasonable success

Operated a convenience and discount store for four years with reasonable success

Operated a temporary Nursing agency, supplying temporary help to Nursing Homes

1999 - 2002 BAYER DIAGNOSTICS, Medfield, Massachusetts

Senior Quality Engineer (Sensors and Reagents Validation and Quality Assurance)

Reviewed experimental test plans (ETP), validation protocols IQ, OQ and PQ, engineering change notices (ECN) and other technical documents for technical content, applicability and compliance with cGMP and ISO 9000 requirements, and for conformance to Bayer Diagnostics policies and procedures

Led the effort in the development of Validation Master Plan and Validation Strategy for a new sensor production facility.

Conducted internal quality audits of sensor manufacturing processes and personnel training and certification

Initiated a plant-wide campaign for all-encompassing process documentation (process testing and inspection Work Instructions, assembly drawings and process) verification for currency, completeness and accuracy, and helped develop a method to continuously monitor changes to manufacturing documents

Organized and taught several validation protocol writing and execution training sessions to the sensor manufacturing process engineering personnel

Effected important changes to key company’s validation policies and procedures (SOPs)

Developed a template for Performance Qualification, and reformatted existing templates for IQ and OQ

Conducted batch record reviews, batch reconciliation and product releases

1997 - 1999 KMI/PAREXEL, Inc., Belmont, Massachusetts

Senior Validation Engineer (pharmaceutical, medical device and biotechnology)

Prepared System specifications and qualification test protocols - Installation (IQ), Operational (OQ) and Performance (PQ), using specialized computer software (Valpro)

Conducted and managed the validation of several computer- controlled systems and process equipment (like CIP systems, tanks, freezers, lyophilizers, and liquefaction and purification systems), analyzing test data, writing deviations and final reports

Developed standard operating procedures (SOPs) and annotated process control diagrams.

Executed Factory Acceptance Test (FAT) of upgraded PLC-controlled/Man-Machine-Interface systems, controlling several process lines consisted of process tanks, water-for-injection (WFI), product transfer lines and associated clean-in-place (CIP) systems.

Prepared detailed comparative analysis of the cGMP and the ISO 9000 requirements for clients

1997 - 1997 PAREXEL, Inc., Waltham, Massachusetts

Clinical Data Manger (Contract Research Organization)

Performed data management functions on data from clinical trials, ensuring conformance to applicable CRFs and proper coding conventions, and flagging Serious Adverse Reactions

1993 - 1997 IBC Industries, Inc., Boston, Massachusetts

Proprietor – Detergents, Household Products and Cosmetics

Established a manufacturing operation and set up a distribution network for eight products

Manufactured and distributed private label detergents, skin care and hair care products

Ensured product conformance to FDA guidelines, and compliance to EPA's environmental policies

1988 - 1993 USCI Division of C. R. Bard, Inc., Billerica, Massachusetts

Project Engineer – New Product Development/R&D (medical devices)

Developed production electroplating process to confer variable radio-opacity to guidewires, allowing enhanced visualization of the tip of the wire during catheterization/fluoroscopy

Developed and validated quality control test methods for deposit thickness, concentricity, adhesion and radio-opacity; and wrote the production specifications

Used several engineering and design tools to facilitate product/process development

Designed & executed optimization experiments for existing manufacturing processes

Attended several clinical trials for guidewires and balloon catheters at area hospitals

Developed lubricious hydrophilic/hydrophobic coatings and various QC test techniques for these processes

Made extensive use of scanning electron microscope (SEM) and energy dispersion of X-ray (EDAX) for surface and corrosion analyses

Used vacuum metallization to achieve conductivity and reflectivity in non-metallic substrates

Used selective etching to achieve an even taper in precious metal cladded wires

Interfaced with, and trained manufacturing and QC personnel, and other internal groups like marketing

Interfaced extensively with suppliers for new technologies and raw material

Managed a team of engineers and technicians, making project timelines and evaluating team performances

1987 - 1988 Ventron Division, Morton Thiokol, Inc., Danvers, Massachusetts

Chemist – Specialty Chemicals Laboratory

Prepared specialty chemicals for universities and research institutions, with special emphasis on the handling of sensitive and pyrophoric materials

1985 Honeywell Information Systems, Inc., Brighton, Massachusetts

Wastewater Treatment Operator/ Process Technician – Printed Circuit Board

Monitored and controlled all stages in the waste water treatment process of electrochemical effluents

Analyzed samples from, and maintained the various plating process lines

1984 Armstrong Laboratory, Inc., West Roxbury, Massachusetts

Manufacturing Technician – Pharmaceuticals and Cosmetics

Product compounding, control and monitoring of product properties and supply rate to the packaging stations

Routine equipment maintenance and minor repairs

EDUCATION

M. S. in Material Science & Engineering, (Incomplete due to lack of funds)

Northeastern University, Boston MA

B. S. in Chemical Engineering, 1987

Northeastern University, Boston MA

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