Objective To apply acquired Validation/QC skills in the area of pharmaceutical manufacturing.
Professional Experience Sharp Corporation, West Caldwell, NJ (formerly Ivers-Lee) (This plant specializes in flexible packaging of pharmaceutical, liquid, creams, tablets, powders, towlettes, transdermal patches, and oral solids) June ••••• to Present Validation Engineer • Prepared and executed numerous equipment qualification protocols (IQ/OQ) for packaging equipment. • Prepared and executed numerous process qualification protocols (PQ/PV) for packaging equipment. • Conducted Engineering Studies for packaging machines. Generated protocols and gathered process parameters for each. • All Engineering Studies and Validation protocols were completed on time. Including, generation of protocols, execution and summary reports. • Led all validation activities for three product launches. Two launches were for pouched products, a cream and an oral solid. The third product was for an oral solid into a bottle. Each product launched on time. • Developed machine operation SOP’s for various packaging equipment from manufacturers such as Automate, Jones, Bivans, Key, Video Jet, Garvens, Ivers-Lee, etc. • Responsible for incorporating the latest CFR••••• parts, •••••, •••••, •••••, & ••••• standards into new and existing protocols and SOP’s. November ••••• June ••••• QC Group Leader • Supervised three QC inspectors who were direct reports. • Assisted in execution of validations. • Approved batch records. • Worked closely with Operations to continually reduce documentation issues through training and enforcements of cGMPs. • Approved non-conforming product releases. • Trained QC inspectors on both Sharp’s and Customer’s procedures.
Bobst Group, Inc, Roseland, NJ July ••••• – July ••••• Buyer • Reduced company spending by •••••% as part of outsourcing program. This resulted in over $•••••,•••••/- savings for Bobst. • Implemented stock replenishment system using QAD software. • Negotiated supply contracts. October ••••• – July ••••• Tooling Coordinator • Evaluated old tooling to be effectively utilized in new manufacturing processes. • Implemented inventory management system for tracking of tooling, jigs and fixtures.
January ••••• – October ••••• CNC Programmer • Created CNC programs for various machine tools. February ••••• – January ••••• Tool Crib Attendant • Calibrated precision measuring instruments. • Inspected work using coordinate measuring machine. • Set tool heights using precision measuring instruments for computer controlled machines.
Education Chubb Institute, Parsippany, NJ Diploma in Computer Programming, ••••• New Jersey Institute of Technology, Newark, NJ Masters of Science in Manufacturing Engineering, ••••••••••GPA ••••• Karnataka State University, Dharwad, India Bachelor of Science in Mechanical Engineering, ••••• Pune University, Pune, India Bachelor of Science in Mathematics, •••••
Skills Have prepared validation protocols for the following types of equipment: • Bottling Lines. • Pouching equipment (horizontal and vertical). • Flow wrappers. • Tip on machines. • Cartoners (horizontal and vertical) • Labeling equipment. • Product sorting. Quality Control Related: • Can calculate AQLs with AQL ruler. • Can operate vacuum tester, pressure tester (internal and external). • Can operate bottle cap torque tester.
Software • IBM-compatible computer equipment. • Microsoft Office: Word, Excel, Power Point and Access. • Programming Language: Oracle ••••• and Visual Basic. • E-mail: Lotus Notes, Outlook. • ERP System – QAD.
Status U.S.A Citizen.
Training Softvision Training Institute, Edison, NJ QA – Tester, •••••