Packaging Validation and Case Development Co-op

ADITYA ANANT KAMAT

Cell: 347-***-**** ******.*******@*****.*** 302 Harrison Ave, Harrison, NJ 07029 https://www.linkedin.com/in/aditya-kamat-341199129

Objective

To secure Packaging/Validation/Process/Quality Engineer position in Pharmaceutical/Medical Device company

Education

New Jersey Institute of Technology (NJIT), Newark, NJ

M.S. Pharmaceutical Engineering (subset of Chemical Engineering), Graduated: May 2018 GPA: 3.31

University of Mumbai, Mumbai, India

Bachelor of Pharmacy, Graduated: May 2015 Major GPA: 3.29

Certifications

Zimmer Biomet Institute, Warsaw, IN

Geometrical Dimensioning and Tolerancing (GD&T) Certification

Center for Pharmaceutical Cleaning Innovation (CPCI), Hillsborough, NJ

Subject Matter Expert (SME) Certification in Cleaning Process Development and Validation

Core Qualifications

Commissioning, Qualification, Validation

Design of Experiment (DOE)

Statistics (SPC, Cpk, Gauge R&R etc.)

Advanced Excel (Pivot table, Macros etc.)

ISO/GMP work experience

Test Method Validation

Equipment Troubleshooting

Project Management

Process Monitoring

Software Skills

Infor ERP XA database, Change Management System, Teamcenter (PLM), SolidWorks, Minitab, InfinityQS, InfoPV, MS Office

Relevant Work Experience

Packaging Validation and Case Development Co-op, Zimmer Biomet, Warsaw, IN January 2018 - May 2018

Coordinated with Validation Team as part of Polaris Remediation project in implementation of validation testing; prepared IQ, OQ, PQ protocols and SOP’s for new and modified processes, equipment installed in ISO 13485 environment

Analyzed validation test data to determine whether systems or processes have met validation criteria; rectified problems related to deviations in test method validation as well as packaging processes

Assisted Packaging Development team for execution as well as validation of physical tests as per ISO 11607 testing on SBS packaging (e.g., dye penetration test, vacuum leak test, drop test, seal strength test, EtO and gamma sterilization test etc.)

Reviewed packaging non-conformances (NCR) for sterile and non-sterile products (Knee, Hip, Trauma, Extremities, Foot & Ankle, Sports-Med business units); performed physical fit check & worst-case assessment w.r.t mass and tip geometry

Performed primary and secondary packaging changes related to Bubble-bag, Square tube, Polybag etc. for non-sterile products and Blister, Poly-urethane pouch, Tyvek, Foam box etc. for sterile implants in ISO environment

Reviewed Product engineering drawing, DHF, DHR and dFMEA to provide rationale if component change does/doesn’t affect I/O risk table, Design Validation (DV) and Work-in-Progress/Released products

Acted as Change Lead in establishing Bill of material (BOM), Work Instruction (WI) & Process routing for related operations

Reduced 85% of packaging component change backlog by working in conjunction with Manufacturing and Quality groups

Packaging Process Development Intern, Bristol-Myers Squibb, New Brunswick, NJ June 2017 - August 2017

Intern Project titled “Vision inspection of embossed variable data on blister cards using Design of Experiment.”

Constructed and evaluated the current Design-of-Experiment (DOE) developed for Cognex Surface-FX vision inspection system to be fitted on aseptic packaging lines

Provided necessary onsite support in the areas of product in-feed, data monitoring, recording for all tested samples and performed statistical analysis using Minitab to provide correct interpretation of results

Increased vision system’s prediction accuracy from 80% to 95.38%, thus determining its robustness, feasibility for replacing manual inspection and implementation on BMS’s Italian, Chinese and Japanese site packaging lines

Prepared a manual based on application principles and techniques used while designing this project model for future reference to GPT and MS&T departments

Summer Intern, Lesanto Pharmaceuticals, Mumbai, India May 2014 - July 2014

Aided Production Manager in calculating actual equipment operating time and performance output for comparison with targeted production time and output respectively to determine overall equipment effectiveness

Coordinated with production team in developing methods for process scale-up and efficient optimization of production process; assisted QA team in BMR review, GMP deviation citation and interfaced with QC team for reports

Conducted periodic quality checks on weight, thickness, hardness and friability at stages of tablet manufacturing process

Performed qualitative and quantitative analysis of in-process samples as well as finished liquid-oral dosage products in QC laboratory using analytical instruments like HPLC, UV-Spectrophotometer, LC-MS, TLC, Viscometer etc.

Projects/Presentation

Project Management project titled “Compilation of Project charter, Work Breakdown Structure (WBS), Management plans and Baselines (Scope, Schedule, Cost and Risk) for Blue Heron City Redevelopment Scheme.”

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