(978) 916-9000 aballum@gmail.

com CHEMICAL ENGINEER/VALIDATION PHARMACEUTICAL, MEDICAL DEVICES A multidisciplinary chemical engineer with a broad background in FDA regulated environments and expertise leading process validation initiatives and GMP-related projects. Recognized as an excellent auditor and investigator. Strong capabilities in communicating concepts, implementing research and managing projects with minimal direction. Hands-on experience in all aspects of computer system and process validation. Highly conversant with data analysis based on the theory of multivariate error propagation. Proven technical writing and documentation capabilities. A team player with exceptional methods development skills, problem solving capabilities and analytical skill combined with an inquisitive mind, imagination and initiative. ENGINEERING EXPERIENCE/EXPERTISE Industry Best Practices (cGMP, cGDP, cGLP), 21CFR Part 11, 820 Process validation protocols (IQs, OQs, PQs) SOPs, Validation Plans, Change Control, Audit Trails Design, Startup, Troubleshooting of experiments Software Testing Methodologies (Test Plans, Scripts, Cases)

ANU BALLUM 60 Dinsmore Ave. Lowell, MA 01852

Broad engineering experience ranging from

research to manufacturing Gap Analysis, Remediation Plans Requirement Traceability Matrix (RTM)

Process Flowcharting, Mapping Computer System Validation Lifecycle

TECHNICAL SKILLS Analytical Equipment GC, HPLC, Autoclaves, Ovens, Incubators, Plate Reader, ICP Mass Spectrophotometer and Lab Instruments (Conductivity Meter, pH meter) Software CHEMCAD, C, Fortran, HTML, Pascal, MS Office, MS Visio, Lotus Notes, Sigma Plot, MATLAB, MS Excel Solver PROFESSIONAL EXPERIENCE Project Catalysts, Inc., Portsmouth, NH February 2006Present Contract Validation Engineer Hired to take a leadership role in significant projects for high visibility clients. The firm is a global consulting & solutions company that large organizations turn to for state-of-the-art solutions. Representative projects include: Tasked to validate a companys Global Complaint System for compliance with FDA medical device regulations. The system is global with over 800 users in 50 countries. Created and executed test cases that identified defects for correction combined with enhancement to ensure the integrity of the system. Created change requests to implement the changes and enhancements made to the system in a controlled manner. All documentation was reviewed and updated for gaps in the system, in preparation for an FDA audit. The result was full compliance with 21 CFR part 11 and part 820 regulations. Assigned to audit an entire validation effort for all products at a major manufacturing site, in preparation of an FDA audit. Conducted a cGMP audit on 22 product families specific to the site involving a review of DFMEA, PFMEA, installation qualification, operational qualification, performance qualification, test method validation reports, master validation plans and master validation reports for all product families. Comprehensive review served as a basis for creating an audit plan, developing an audit strategy and defining audit checklists

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Designated lead to validate software to ensure conformance with FDA regulation. All test plans,

design input documents, software specifications and user requirements were investigated followed by creation of validation plans and a requirements traceability matrix to track changing requirements. Conducted manual testing, analyzed test scripts and performed unit integration and system testing. Collaborated with software developers to ensure inclusion of features to enhance the software.

Oklahoma State University, Stillwater, OK 20022005 Research Assistant Original research thesis project identified approaches to address problems facing the water treatment industry. Conducted library research and generated calibration charts and breakthrough curves for calcium and magnesium ions experimentally. Modeled fluid flow inside a packed bed column using numerical methods based on reaction mechanisms, kinetics and mass transfer phenomena. Marim Ltd, Hyderabad, India Research Assistant 20002001 Performed unit material and energy balances for a chemical plant producing sodium carboxyl methyl cellulose. Redesigned reactor, mixing unit, heat exchanger and distillation column to improve process economics. Modified a process flow diagram resulting a cost savings of 5.9% Venkateswara College of Engineering, India 19992000 Graduate Research Assistant Developed a cost-effective technique to produce phosphate conversion coating on mild steel as a pretreatment for cathodic electrophoretic painting in the automobile industry, improving chemical and thermal stability by 10%. Presented findings at NACE and awarded best paper by NACE. EDUCATION MS, Engineering, Oklahoma State University, Stillwater, OK, 3.9/4.0, 2005, Honors: Department Graduate Research Assistantship BS, Engineering, University of Madras, India PROFESSIONAL AFFILIATIONS American Institute of Chemical Engineers Association of Chemical Technologists Indian Institute of Chemical Engineers PUBLICATIONS AND PAPERS Phosphate Pretreatment for Cathodic Electrophoretic-A Novel Approach, K. Ravichandran, B. Anu, C. Tharika, S. Lakshmi, TSN Sankaranarayanan, Industrial Corrosion Causes and Mitigation, Quest Publications, 2000 Masters Thesis Ion Exchange Kinetics and Water Treatment-Devised an experimental procedure to measure capacity of strong acid cation resin.