Engineer Microsoft Office

KRUNAL H. SHAH

E-mail: ************@*****.*** Cell: 860-***-**** Connecticut

Objective: Seeking a full time position in a leading pharmaceutical or Medical device company to create value for the company

Experience: Infotree Service Inc. (Client Medtronic) August 2015 - Current Manufacturing Engineer

Prepared and executed IQ, OQ and PQ protocols and reports of the manufacturing and packaging equipment such as Multivac, Alloyd Sealer, Stringer Machine, Sonic Welder, Water Bath, Oak Mixture, Hawo Sealer etc.

Performed the software validation protocol and report for the manufacturing equipment (Oak Mixture, Sonic Welders, Bellmark printer) and Agile document portal.

Served as a resource to and facilitate CAPA investigations including data analysis, root cause analysis and developing/implementing corrective action plans

Prepared and executed accelerated and real time shelf-life testing (T1, T3 and T5) for new packaging material combinations.

Prepared and executed Transportation study (Conditioning study, Compression, Shock, Vibration study) protocols and reports by following ISTA 2A guidelines.

Prepared and execute the gauge R&R protocols and reports for the various test method.

Performed the process characterization study (ANOVA analysis, DoE, Surface response analysis) to established the operating range parameter for the new equipment.

Performed data analysis in Minitab by using tools such as process capability, tolerance interval, 2- sample T test, paired T-test, Gauge R & R, non-normal data analysis).

Create the label specification, BOM, pre-production component and production component for new material into the design history file (DHF).

Worked with the Quality Engineers to determine the root cause of the non-conformance reports and address those changes by making current process more robust.

Developed, improve and maintain new and existing manufacturing process including the creation of manufacturing processing documentation and equipment operating equipment.

Developed rework procedure for over labeling and validate the process.

Write the work instruction of the current manufacturing process and trained manufacturing operators on to the new work instruction.

Prepared and approved Engineering drawing for the manufacturing parts in windchill and Agile. Amneal Pharmaceutical June 2015-August 2015

Contract Validation engineer

Prepared and execution of IQ, OQ and PQ of various equipment (MGS eclipse cartoner, V-blender, Oven, Stability chamber)

Prepared and execute the protocol and report for a HVAC and new build area at Amneal Pharmaceutical

Write the change control report

Write various technical document such as deviation report, CAPA and root cause analysis PAR pharmaceutical, Spring valley, NY, USA Jan 2015- May 2015 Co-op student as a Process engineer

Received training on SOP of Engineering, QA, CV and packaging

Prepared and executed IQ,OQ and PQ of various equipment (Kikusui Tablet press,, Slat filler Woowon mixer, Schmidt assembly press, Hibar pump, IVEK pump, Burster monitor)

Prepared SOPs for installation, operation and cleaning of equipment

Interface with other internal organization such as manufacturing, R&D, packaging, as well as external customers and suppliers on projects, processes or equipment.

Miscellaneous technical data generation and analysis using PC based tools or field observations/measurements. These tasks involve writing reports, preparing/delivering presentations along with other engineering professionals.

Assists in inventing/creating concepts and designs/approaches for new processes/test methods.

Summarizes, analyzes, and provides recommendations from test results.

Performs troubleshooting on existing products/process problems as related to design, processes. Ami life science, Gujarat, India Oct 2010 –July 2011 Quality Assurance Trainee

Participated in the development, management and maintenance of GMP compliant documents

Issued Batch production control record and validate the filled BPCR

coordinate and support on-site audits conducted by external providers

Devise sampling procedures and directions for recording and reporting quality data

Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality

Develop, recommend and monitor corrective and preventive

Responsible for document management systems and assure ongoing compliance with quality and industry regulatory requirements

Skills: Validations skills:

Preparation of technical document: IQ, OQ, PQ,ASTM, SOP, URS, VMP, DoE, FMEA, Trace matrix, Commissioning, FAT, SAT. Change control

Cleaning validation: Sampling method, Cleaning process control, CIP, COP Quality tools:

CAPA, Lean Six Sigma, Root cause analysis, Fishbone, Process capability study, Gage R&R, ANOVA, Total quality management, Process Analytical Technology, QbD, Quality audits, ICH and 21 CFR 210. 211, 11 and 820 guidelines, 7 step model, Identifying deviation Skills: Team leader, multi-tasking, organized, detail-oriented, flexible and adaptable to changes Effective written and verbal communication skills

Computer Skills: Microsoft Office, Microsoft Project, Visio, Minitab 17, AutoCAD, Agile, Trackwise, Wind chill, Solid works, Automation Studio

Education: Master of Science in Pharmaceutical manufacturing GPA: 3.47 Jan. 2014- May 2015 Stevens Institute of Technology, Hoboken, NJ

Master of Pharmacology GPA: 3.87 Sept.2011- July 2013 Gujarat Technological University, Gujarat, India

Bachelor of Pharmacy GPA: 3.72 Sept.2006-Aug.2010

RGUHS, Bangalore, India

Projects:

Development of a product formulation and process and validate the product and process cycle.

User Requirement Specifications for Fluidized Bed Dryer

Installation and operational qualifications for the Mixer

Analyzed and Discussed Quality Trends observed in FDA Warning Letters. Publications: Evaluation of the Hepatoprotective activity of polyherbal formulation in Paracetamol induced Hepatotoxicity in rats (http://globalresearchonline.net/journalcontents/v22-1/25.pdf)

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