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Prahar S. Vaidya

Process Engineer II

Lonza 

Phone: 216-925-6615

E-mail: prahar.vaidya@outlook.com

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Summary

Quality Centric Process Engineer working in a cross-functional role in a highly dynamic biopharmaceutical environment who undertakes complex challenges exceeds goals and delivers superior performance. Holds a Master of Science in Chemical Engineering degree with a solid foundation in developing, planning, and coordinating operations and continuous improvements.

Creativity combined with unwavering conviction and planning to see complex projects to the finish line, I enjoy challenges and aim to energize my team, help cultivate a positive team environment to do the same. I am collaborative, meticulous, and results-driven and I welcome opportunities that lend me the ability to let my enthusiasm & creativity flourish, be even more data driven, all while learning from solving organizational challenges.

A summary of the skills, I can bring to your management team includes:

• A well-versed chemical engineer experienced working at a CDMO Drug Substance manufacturing facility comply with ISO, FDA regulations (21 CFR 11, 21 CFR 210, 21 CFR 211, 21 CFR 111, 21 CFR 117, ICH Q7)

• Experienced with Tech Transfer, Commissioning Qualifications & Start-Up, Equipment Trials/ Purchasing and FATs/SATs, Capital Investment projects in a highly agile cross-functional team

• Demonstrated knowledge of Change Control Management, DOE, Deviation, Investigation, CAPA, and Root Cause Analysis

• Lean Six Sigma Greenbelt Certified professional and capable of supporting Continuous Improvement Initiative and strategizing Organizational CI Road Map/ KPIs / X-Matrix/ Departmental A3s

• Researcher in the field of Material characterization with 2 publications, experienced with Laboratory practices, conceptualization & execution of experimental studies, sample preparation and method development, gathering analytical data, data analysis and interpretation using statistical software (Minitab, SPSS, SigmaStat) as well as parameter estimation and optimization

• Working knowledge of Solidworks/ AutoCAD, engineering drawing with GD&T as I have served in Aerospace/ medical device manufacturing facility

• Provider of education workshops and seminars on Engineering, provided guidance though tutoring and aimed to foster science by developing awareness in future generation

Skills

Chromatography,

Filtration and Ultrafiltration/Diafiltration, DeltaV,

OSI PI,

Deviation/ Investigation, Change Control (TrackWise), DMS,

Corrective and Preventive Action (CAPA),

Failure Mode and Effect Analysis (FMEA),

HACCP,

FDA Regulatory Compliance, cGMP,

Data analysis and statistics (Minitab),

ERP/ CMMS applications (SAP, Epicor),

Hoshin Kanri,

Strategic X-Matrix,

A3 planning/ deployment/ execution,

Lean Six Sigma Methodologies, 8 Step Problem Solving and Waste analysis,

Gemba Walks, Material Characterization/ Adsorption, CAD/ CAM (SolidWorks/ AutoCAD), Design of Experiments (DOE)

Work Experience
​​S. S. White Technologies, Piscataway, NJ
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Manufacturing Intern, October 2016- Present

  • Worked in a team with Product Development Engineers to generate Method of Manufacturing (MOM), routers, Inspection plans using QSI Module, test fixtures, tools/ adapters for new projects and contract manufacturing products in accordance with customer requirements

  • By understanding product application and expectations, translated customer requirements into product specifications in accordance with manufacturing capabilities utilizing possible failure modes (DFMEA)

  • Resolved various manufacturing issues & non-conformances by Root cause analysis, Corrective and preventive action (CAPA) and prototyping

  • Liaison between the manufacturing operators and Manufacturing/ Product Development engineers as well as Sales/ Planning team to propose delivery date for upcoming products

  • Conducted Time studies as well as providing manufacturing data

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Engineering Intern, May 2015- August 2015​

  • Worked with a team to convert AutoCAD drawings to SolidWorks drawings utilizing Geometric Dimensioning and Tolerancing (GD&T) for Medical and Aerospace parts which helped the company to considerably increase efficiency of the manufacturing process

  • Worked in a team aiming to generate routers and pictorial instructions for manufacturing of medical and aerospace parts which can be helpful to new hires, documentation of standardized procedures (SOPs) for regulatory compliance (ISO, FDA) and reviewed drawings/assembly layouts

  • ​​Worked in team to maintain and manage router effectiveness metric, SOP, BOM, Inspection Database for Class 1 and 2 medical devices (clean room 10,000 Class), Orthopedic Flexible trephines, making sure that the operation runs to plan while minimizing quality issues

  • Acquainted with the major software used in ERP (Epicor) for scheduling, material requirement & inventory planning so as to generate a purchase order

  • Acquainted with basic Lathe operations

 
Cleveland State University, Cleveland, OH

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Graduate Research Assistant, Chemical & Biomedical Engineering,
January 2014- May 2016

  • Researched on BINARY GAS ADSORPTION on Silicalite under the guidance of Dr. Orhan Talu at Cleveland State University and thus strengthening my knowledge of the MATERIAL CHARACTERIZATION & ADSORPTION PHENOMENA.

  • Conceptualization on Binary Gas Adsorption and execution of various experimental studies performed on Pure and Binary mixture of various gases, gathering more analytical data to contrast more on Net/Excess/Absolute Adsorption, solid characterization and potential use of Silicalite for Natural gas enrichment

  • The measurement techniques, advantages and disadvantages were discussed and data was examined for thermodynamic consistency and compared to ideal adsorbed solution predictions for both net and excess adsorption.

  • Solid adsorbent (Silicalite, ETS-10, LiLSX) material characterization (surface morphology, surface area, pore size, density) using SEM, Gas Pycnometry, mercury displacement & gas adsorption techniques 

  • Experienced with installing, troubleshooting, calibrating and maintaining process analytical instruments including but not limited to Gas chromatograph, Mass spectrometer, SEM, Porosimeter, Differential scanning calorimeter, etc.

  • Acquainted with major data analysis and statistical softwares (Minitab, SPSS, SigmaStat)

  • Conference proceeding and  Technical paper:

1) Vaidya, P., Moran, A., and Talu, O. (2014). “Pure and Binary Net Adsorption of CH4, CO2 and C2H4.” AICHE Annual meeting, Atlanta, GA. ISBN: 978-0-8169-1086-1

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2) Vaidya, P. (2016). "PURE AND BINARY ADSORPTION OF METHANE AND NITROGEN ON SILICALITE." Electronic Thesis or Dissertation. Cleveland State University, 2016. OhioLINK Electronic Theses and Dissertations Center

 

Chemical Engineering Tutor & Recruiter Specialist, January 2014- May 2016

  • Assisted undergraduate students in achieving a better understanding of calculus and engineering courses

  • Helped students develop confidence in themselves and a positive attitude towards engineering

  • Helped over 2000 high school students to learn about the engineering profession and its benefits

  • Assisted with daily office responsibility, student walk-ins, and helped manage tutoring service

 

Teaching Assistant, Chemical & Biomedical Engineering, August 2014- May 2015​

  • Assisted Prof. D B Shah with Grading homework assignments and exams in one of the Undergrad subject TRANSPORT PHENOMENA

  • Assisted Prof. Joanne M. Belovich with Grading homework assignments and quizzes in one of the Undergraduate subject CHEMICAL ENGINEERING PRINCIPLES

  • Prepared materials, proctored exams, held office hours to consult with individual students

 
Nitrex Chemicals, Gujarat, India
 

Chemical Process Engineer, July 2012 - June 2013

  • Investigated and reviewed Piping & Instrumentation Diagrams (P&ID), computed the pressure distribution and velocities across streams which would help the company for future expansion and production capacity of Nitrocellulose 

  • Learned simulation of the distillation column which basically regenerates iso-propyl alcohol used in nitrocellulose as a damping medium thereby helping the company in a way that handling the supervision of the dehydration unit was done independently

  • Worked closely with process chemists and chemical technicians to ensure maximum output levels and the efficient running of the production facility

  • “Hazardous Safety Training” at Reliance Industries Manufacturing Division, Dahej, Bharuch. (Fortune Global 500 rank #99)

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Gujarat Narmada Valley Fertilizers and chemicals Company Limited, Bharuch, India

 

Engineering Intern, June 2011-July 2011

  • Studied the principles of production of methanol based on partial oxidation of oil and reforming processes of Synthetic Natural Gas (syngas) 

  • Acquainted with panel operation of the plant on DCS (Honeywell)

  • Analyzed the material and energy balance across important unit operations of the plant

Programming Languages

C Programming language,

Python

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Education​, Licenses & Certifications
Lonza Operations Excellence Training Academy
Lean Six Sigma Green Belt – Certificate Number : 2021-3110
October 2021
 
Project Management Institute, Inc.
Operations Management Foundations - Certification Number : 
January 2017
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Cleveland State University, Cleveland, OH

Master of Science (M.S.) in Chemical Engineering - Cum Laude

GPA: 3.50, August 2013- May 2016

 

Research: Pure and binary adsorption of methane and nitrogen on Silicalite

Project: Adsorption column packing retainer for better gas distribution at reduced pressure drop

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Relevant course works:

Advanced Thermodynamics (CHE 502), 

Advanced Reactor Design ( CHE 504), 

Advanced Transport Phenomena (CHE 506), 

Colloidal/Interfacial Phenomena (CHE 694), 

Fuel Cells (CHE 594),

Fundamentals of Polymers (CHE 586).

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Gujarat Technological University, Gujarat, India

Bachelor of Technology (B. Tech) in Chemical Engineering

GPA: 3.35, June 2008- May 2012

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Project: Debottlenecking of Methanol-Water Distillation column

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Relevant course works: 

Chemical Engineering Thermodynamics,

Process Heat Transfer,

Process Equipment Design,

Instrumentation and Process Control,

Mass Transfer Operation,

Computer Aided Process Synthesis,

Plant Design And Project Engineering,

New Separation Techniques,

Chemical Reaction Engineering,

Petroleum Refining And Petrochemicals,

Process Simulation And Optimization,

Physical And Inorganic Chemistry,

Mass Transfer Operation,

Mechanical Operation,

Chemical Process Industries,

Pollution Control and Safety Management,

Energy Technology,

Multi Component Distillation,

Organic chemistry and unit processes,

Process Calculation,

Fluid Flow Operation,

Mathematics,

Management,

C Programming.

Leadership
The American Society of Engineers of Indian Origin (ASEI), OHIO Chapter

Treasurer, August 2015- May 2016

  • Financial planning and budgeting of events

  • Gathering students for Funding, fundraising and sales events being held on-campus

  • Cultivating relations with alumni and maintain funds & financial reporting to head office

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Bachhpan, Non-Governmental Organization (NGO), Gujarat, India

Volunteer, May 2011- May 2013

  • An organization intended to eradicate the horrific practice of child-labor and bring awareness about the importance of education in slum areas

  • Raised INR 100,000 for the property to build classrooms to educate the poor and needy children to make their road-map towards bright future

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Extra-Curricular Activities
  • Participated in the “National Symposium” on Advance in ‘Separation and Purification Science & Technology’ organized by the Department of Chemical Engineering, G.H.Patel College of Engineering and Technology, VVnagar on January – 2011
     

  • Participated in “Purifier”’ Event of ‘Chemhunter’ in ‘INFINITI 09’ a national level technical fiesta organized by G.H. Patel College of Engineering and technology, VVnagar
     

  • Attended a workshop on “Heat exchanger” at Chemozale ’10 organized by ChESA, NIRMA-2010
     

  • “Hazardous Safety Training” at Reliance Industries Manufacturing Division, Dahej, Bharuch. (Fortune Global 500 rank #99)

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