Validation Engineer

CHANDNI N. GANDHI

***, ******* ******, *** # *, Jersey City, NJ-07306

E-mail: abgnzd@r.postjobfree.com Mobile: 909-***-****

Education: Master of Science in Pharmaceutical Manufacturing Engineering Aug 2013 - Dec 2014

Stevens Institute of Technology - Hoboken, New Jersey

GPA: 3.67

Bachelor in Pharmacy July 2007 - April 2011

University of Pune - Maharashtra, India

GPA: 3.50

Skills:

Validation skills- Calibration, Validation and Qualification of Equipments, Risk assessments,

Commissioning, IQ, OQ, PQ, Cleaning validation, SOP writing

Software skills- Minitab 17 (Statistical tool), M-files (Electronic Documentation), SharePoint,

TrackPro, MS Office, MS Word, MS Excel, MS PowerPoint, MS Project

Analytical skills- Dissolution, Disintegration, pH analyzer, TOC analyzer, HPLC, TLC, HPLC,

Tablet press operations

Manufacturing skills- Lean six sigma basics, DoE, PAT, FMEA, Process Capability, Gage R&R,

Root Cause Analysis

Quality skills-21 CFR Part 210, 211 and 11, ICH guidelines, cGMP, GLP, QbD, CAPA, 7 Step

model for ethical decision making

Team leader, multi-tasking, organized, detail-oriented, flexible and adaptable to changes

Effective written and verbal communication skills

Experience: Stevens Pharmaceutical Research Center, Hoboken, NJ Aug-Dec 2014

Process Development Scientist in a course project

Developed the formulation process flow diagrams for the industry level tablets using Minitab 17-

FMEA and DoE

Developed SOPs for TOC and HPLC analysis

Prepared Batch manufacturing records

Worked with TOC and HPLC for Cleaning validation and content uniformity

Prepared bill of materials, content uniformity spreadsheet

Baroque Pharmaceuticals Pvt. Limited July 2011-Jan 2012

Production Chemist / Validation Engineer (Intern)

Compiled Batch manufacturing records for various parenteral drugs such as Paracetamol and

Adrenaline

Sampled raw materials, active ingredients and excipients

Reviewed and updated SOPs of various manufacturing processes

Participated in development and enhancement of quality standard as per GMP requirements

Projects:

Process development, production and quality testing of Theobromine tablets

Site Acceptance Test (SAT) for Depyrogenation tunnel

Paper presentation on ‘Anti-counterfeiting and e-pedigree’-Trends and Technologies

Design of manufacturing facility for Ophthalmic solutions

SOP for blending using V-blender

Activities:

Member of Stevens Pharmaceutical Research Center (SPRC), Women in Pharma and ISPE

Member of Indian Pharmaceutical Association- Students Forum

Active volunteer for CRY America and LIVESTRONG foundation

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