CHRISTY JOSE MATHEW

*** ***** ****** **., ***** Wales, PA 19454

Phone: 267-***-**** Email ID: acvh5q@r.postjobfree.com SUMMARY:

Process, Manufacturing, & Product Engineering professional with previous experience in process development and troubleshooting in manufacturing/ cGMP (Production, Development, Process Engineering, Technical Services) pharmaceutical/ biotech/ life sciences environments; detailed knowledge and exposure to aseptic techniques, purification, and analytical instrumentation.

Solid command of technologies, tools and best practices in designing mechanical equipment using SolidWorks and engineering drawings.

Excellent experience driving process engineering, manufacturing and quality system compliance within highly regulated Pharmaceutical/ Life Sciences industries. Able to coordinate and work on oral solid drugs Manufacturing and Properties Solid command of technologies, tools and best practices in designing mechanical equipment using SolidWorks and engineering drawings.

Capable of managing several assignments/ projects utilizing strong team collaboration skills; excellent communication (written and verbal) skills; working cross-functionally and collectively with team members to achieve goals in pharmaceutical/ vaccines/ biologics development and manufacturing, as well as, technology/ process/ product transfers, trend monitoring, deviation management, and process engineering.

Extensive experience providing engineering, change control, and deviation identification/ investigation, and management support to production stages of pharmaceutical/ drug development; managing entire development cycle of capsules, tablets and suspensions; testing all properties for production; performing root cause analysis, and identifying material discrepancies and process/ material non-conformances and deviations.

Performed Process & Equipment Validations (IQ, OQ, PQ); troubleshot and validated process and ensured compliance with internal and external quality and regulatory requirements and standards (FDA/ ISO/ GMP).

Direct experience managing production teams supporting change control from both internal and external sources for raw materials, processing, and packaging components for Pharmaceutical products and materials manufactured; coordinating/ communicating with vendors; executing multiple projects against key timing commitments, and generating associated documentation (technical documents, controlled documentation, SOP’s protocols, KPI’s, metrics).

Experience in Dissolution, HPLC, filter integrity tests, setup of filtration skids/ PODs, automation/ process troubleshooting, and other pharmaceutical equipment’s. Experience with aseptic and purification techniques as well as, analytical instrumentation. Experience in handling and troubleshooting machines high shear mixer, V- blender, Fitz-mill, Fluid bed dryer, Capsugel, and Capsule filling machine (In-cap bonaspace indott).

Ability to support Upstream Cell Culture and Fermentation GMP operations, raw material inspections, Deviation reports, Root Cause Analysis investigations, Corrective & Preventative Action implementation

Effectively troubleshot failures and irregularities on process equipment, automation, and inventory issues. Supported Change Controls, drove Process improvements, and assisted in Maintenance/ Validation production scheduling

Bachelors in Mechanical Engineering; Courses/ Training: Engineering Analysis, Measurement and Instrumentation, Industrial Processes, Elements of Material Engineering, Thermal Systems Laboratory, Heat and Mass Transfer, Statics, Dynamics, Mechanics of Materials, Fluid Mechanics, Dynamics of Machinery, Mechanical Engineering Thermodynamics, Machine Design, Mechanical Vibrations

Certifications: Quality Control NDT (ASNT LEVEL II): Liquid Penetrant Testing. Magnetic Particle Testing. Radiography Testing. Ultrasonic Testing; Training/ Diploma- Piping Engineering: Process Piping Design and Engineering as per ASME B-31.3; Technical Skills: SolidWorks, Solidedge, C, C++, Oracle SQL, MS Office. PROFESSIONAL EXPERIENCE:

Carnegie Pharmaceuticals, Monmouth Jct., NJ 2015 – Present Engineer

Provided engineering, change control, and deviation identification/ investigation, and management support to the production stage of the drug. Responsible for managing the all development cycle of capsules, tablets and suspensions.

Testing all properties for the production. Identify material discrepancies and process/ material non-conformances and deviations. Experience with aseptic and purification techniques as well as, analytical instrumentation

Performed Process & Equipment Validations (IQ, OQ, PQ); troubleshot and validated process and ensured compliance with internal and external quality and regulatory requirements and standards (FDA/ ISO/ GMP)

Responsible for managing the production team supporting change control from both internal and external sources for raw materials, processing, and packaging components for Pharmaceutical products and materials manufactured. Coordinate and communicate with vendors

Experience in Dissolution, HPLC, filter integrity tests, setup of filtration skids/ PODs, automation/ process troubleshooting, and other pharmaceutical equipment’s.

Experience in handling and troubleshooting machines high shear mixer, V- blender, Fitz-mill, Fluid bed dryer, Capsugel, and Capsule filling machine (In-cap bonaspace indott).

Supported Upstream Cell Culture and Fermentation GMP operations, raw material inspections, Deviation reports, Root Cause Analysis investigations, Corrective & Preventative Action implementation

Effectively troubleshot failures and irregularities on process equipment, automation, and inventory issues

Technical Standard Operating Procedure (SOP) and Batch Document revisions. Working with EHS, GMP cleaning, and Production to identify any gaps between procedures and current practices

Supported Change Controls, drove Process improvements, and assisted in Maintenance/Validation production scheduling

Responsible for executing multiple projects against key timing commitments, generating associated documentation (technical documents, controlled documentation, SOP’s protocols, KPI’s, metrics). Northtec LLC, Trevose, PA 2015

Manufacturing/ Production Line Engineer (Part time)

Responsible for managing the production line.

Responsible for inspecting, shifting, and approving raw materials and finished goods.

Identified non-conformances, defects, discrepancies, and deviations for raw materials, finished goods, and associated processes.

Work and support multiple areas as needed including operations, quality, technology, and external organizations. KMML (Kerala Metals and Minerals Limited) & J. Dezigns LTD, 2013 Process Engineering & Project Management Internship

Managed and plan execution of projects timeline from inception to submission.

Assisted in the Designing and production of the remodeling parts of vehicles and fix it.

Maintenance and working of horizontal Reciprocating Compressor.

Assisted in the Working and Processes of Boiler Plant.

Assisted in the Mechanical maintenance section for welding of TIG, MIG and ARC. EDUCATION:

Bachelor of Technology in Mechanical Engineering (WES Evaluated), May 2015 Mahatma Gandhi University. Kottayam, Kerala, INDIA. Courses/ Training: Statics, Dynamics, Engineering Analysis, Mechanics of Materials, Fluid Mechanics, Dynamics of Machinery, Measurement and Instrumentation, Mechanical Engineering Thermodynamics, Industrial Processes, Elements of Material Engineering, Machine Design, Mechanical Vibrations, Thermal Systems Laboratory, Heat and Mass Transfer

Higher Secondary- Computer Science March 2011

Mount Bethany. E.H.S. School, Mylapra, Kerala, INDIA. CERTIFICATIONS:

Quality Control NDT (ASNT LEVEL II): Liquid Penetrant Testing. Magnetic Particle Testing. Radiography Testing. Ultrasonic Testing.

Diploma In Piping Engineering: Process Piping Design and Engineering as per ASME B-31.3.

STED Council Of India Certificate in HVAC

Heat Ventilation and Air Conditioning (HVAC) as per ASHRAE and ISHRAE standards. TECHNICAL SKILLS:

Programs: SolidWorks, Solidedge, C, C++, Oracle SQL, MS Office.

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