Engineer Engineering

BACKGROUND

Experience as a Metrologist/Validation Engineer in GMP rated Pharmaceutical Company with a wide-ranging proficiency in Equipment, Facility, Computerized system, and Utility Qualification.

Experience as a PAT Engineer in automating the pharmaceutical process with the robust quality and reliability.

Authored various IPC and POMS recipe for material preparation, gelatin, encapsulation and finishing

Supported IPC projects for automation systems in the production floor.

Solid knowledge on Manufacturing Execution systems (MES) software POMS.Web and POMS

Certified on product design software such as AUTOCAD, Pro-E, CATIA, GD&T and Simwise 4D software.

Expertise in Equipment, lab equipment and Facility Validation Pharmaceutical Process and Packaging Engineering Project and Production Engineering Facilities and Safety Engineering.

Extensive Validation and Commissioning experience with Engineering Equipment and Instrumentation and all associated software.

Solid experience in working with the cGMP, MHRA, DEA, 21 CFR part 820, 210 – 212 and FDA regulated Environment.

Written and Executed IQ/OQ/PQ, FR and DS, SOP, FMEA, Job safety analysis, Ergonomic assessment, Lock out tag out (LOTO) procedure for equipment.

Solid knowledge on working with bio-life science, solid dosage and soft gel manufacturing environment.

Performed a thermal mapping of the warehouse, Walk-In Refrigerator, Walk-In freezer, Refrigerator Freezer, stability chamber, DEA Vault and hot box

Hands on skills on troubleshooting, calibrating and problem-solving skills on equipment.

Executed a software IOQ on various Engineering equipment such as autoclave, Single channel pump and CIP tank.

Worked on Allen Bradley HMI equipped Instruments such as autoclave, single channel electronic pump and CIP skid.

EQUIPMENT/SYSTEMS

CIP Skid, Single channel electronic pump, Autoclave, Encapsulation, IPC, POMS, HPLC, GC, Polarimeter, Water bath, Stability Chamber, Walk-In freezer, Walk-In Stability Chamber, Refrigerator, Walk-In Refrigerator, Hot box, Incubator, Vault, Retain room and Warehouse, Freezer, Ultra Low Freezer, Halogen moisture analyzer, pH meter, Fume hood, Potent hood, Karl Fischer Titrator, Balance, Dissolution Autosampler, ICP, Air handlers, Fiber optics, Gas flow meter, Multimeter, Fluke process calibrator, kaye validator, RTD and Potentiometric titrator.

SOFTWARE: Vlog Veriteq, ViewLinc, AUTOCAD, Pro-E, CATIA, GD&T, TrackWise, Studio 5000, RS logix, CDMS (Documentum), JD Edward (CMMS), POMS.web, POMS (MES), Empower 3, Vaisala INC, MadgeTech and HOBOware.

EDUCATION

Master of Science in Mechanical Engineering - Gannon University, Erie, PA December 2015

Bachelor of Engineer in Mechanical Engineering – Velammal Engineering College, India June 2010

EMPLOYMENT EXPERIENCE

Catalent Pharma Solutions

Saint Petersburg, FL October 2016 – May 2020

Metrologist\Validation Engineer

Catalent Pharma Solutions

Saint Petersburg, FL June 2020 – Present

PAT Engineer, Automation Engineering

PROFESSIONAL EXPERIENCE

Written and Executed IQ, OQ, PQ, FR and DS for the single channel HPLC, Powder safe Balance Enclosure, Karl Fischer Titrator, Halogen Moisture Analyzer, Dissolution Auto-sampler, Ovens, Polarimeter including equipment and room utilities.

Performed a temperature and humidity mapping for Stability Chamber, Walk-In Refrigerator, Refrigerator, Incubator, Vault, Retain room and Warehouse and Ultra-low freezer, Freezer.

Executed the software IOQ on Vaisala, Madge Tech and Hoboware data logger software.

Drafted the Commissioning Plan and Master Validation Plan for a new facility being renovated for cGMP manufacturing.

Collaborated with the automation team 24/7 to support to minimize downtime as it relates to the manufacturing process.

Initiated and executed the Change control in the Current compliance system (TrackWise) and Computerized Database Management System (CDMS).

Developed the project plans, contingency plan, project documentation and provide updates to customers.

Written a standard operating procedure (SOP’s) for various equipment. Polarimeter, Halogen moisture analyzer, Replacement of HEPA and Pre-Filters from the Potent Hood.

Written and executed IOPQ, FAT, SAT, URS, SRS, validation plan, 21 CFR Part 11 Assessment, and Validation summary report for various lab equipment, facility, utility, and manufacturing equipment.

Executed a thermal validation activity to verify the Air handler functionality, cold storage rooms, DEA chamber, Walk-In’s qualification projects.

Experience in working with controlled environment and executed the temperature/ humidity mapping for the entire controlled site.

Worked cross-functionally with QA, QC, Engineering, Manufacturing and Facility teams to improve the process.

Performed the software IQ, OQ, and PQ of fully automated CIP skids, autoclave, single channel E-pump.

Worked on Computerized maintenance management system (CMMS) to track the calibration and preventive maintenance and periodic re-mapping of the laboratory equipment and instruments.

Knowledge on writing investigations, discrepancy report, initiating change control and execution of Corrective and Preventive action (CAPA).

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