Sneha Chauhan

31 Minebrook Road, Apt # 169B, Edison, NJ 08820 | 848-219-5513 | chauhansneha0310@gmail.com

SUMMARY
Experience as a Validation Engineer for 4 years in the pharmaceutical company. Extensive experience of Process
engineering, Equipment and Process Validation and Quality compliance within the cGMP, FDA regulations, ISO and
ICH guidelines. Increasing productivity and quality through keen data analysis, process design; significantly improve
operations and provide efficient resolution of engineering and production issues. Excel at completing the projects
accurately, on time, and within the budget. Proficient with AutoCAD, Minitab, Excel, Word, Power point, outstanding
communication skills and management skills. Detailed Knowledge of Process development, Cleaning validation, CAPA,
Root cause analysis, Risk investigation, Risk management and Lean Six Sigma.

EDUCATION
Stevens Institute of Technology, Hoboken, NJ August 2013 - December 2014
M.S. in Pharmaceutical Manufacturing
Relevant Courses: Lean Six Sigma, Quality in Pharmaceutical Manufacturing, Contemporary Concepts in
Pharmaceutical Validation, GMP for Pharmaceutical Facilities, Regulation and Compliance, Validation and
Regulatory Affairs, Project Management fundamentals, Design and Management of Aseptic Pharmaceutical
Manufacturing Processes, Engineering Economics & Cost Analysis

Rofel Shri G.M. Bilakhia College of Pharmacy, Gujarat, India August 2008 – June2012
Bachelors of Pharmacy
Relevant Courses: Pharmaceutical Analysis, Pharmaceutical Technology, Pharmacology, Dosage Form Design,
Clinical Pharmacy, Medicinal Chemistry, Pharmaceutical Engineering.

PROFESSIONAL EXPERIENCE

Amneal Pharmaceuticals, Inc. Brookhaven, NY

Validation Engineer April 2015 – Present

 Subject matter expertise (Qualification of Equipment, Facility, Utility, Process and Cleaning Validation)
 Generate/Execute/Review validation protocols (IQ/OQ/PQ/DQ) for the pharmaceutical equipments for Mixing,
Compression, Packaging, Softgel, Pharmacy, Coating and Laboratory to meet cGMP and FDA regulations and
guidelines.
 PLC, Software and Optel Vision System Qualification.
 Perform SAT (Site Acceptance Test), FAT (Factory Acceptance Test) for the pharmaceutical equipments.
 Lead, coordinate and perform process validation and post approval changes (commercial, R&D products, scale-
up, scale-down), cleaning validation activities and collect and interpret data using appropriate statistical tools,
compose validation summary reports.
 Generate/Execute/Review Validation Protocols (IQ/OQ/PQ) for pharmaceutical manufacturing facility
(Production rooms, Warehouse, QA Sampling Rooms.) and utility qualification (Compressed Air system,
HVAC system, Humidity control system, Dust collection system, Vacuum system, Purified (De-ionized) water
system)
 Lead tasks and perform independent validation activities, co-ordinate activities with cross functional team,
production, QA and compliance for the execution of the tasks and keep the stakeholders updated.
 Develop and maintain the Validation Master Plan and the Calibration Schedule.
 Develop the Preventive Maintenance Program Schedule for equipments, utilities and prepare the Standard
Operating Procedures (SOPs)
 Lead, support and coordinate with the vendors/contractors for the installation of new equipment, engineering
project execution and meeting deadlines.
 Raise Change Control to make any changes/modify the existing procedure/equipment or introduction of new
method/equipment in the system.
 Perform/Investigate Discrepancy Reports, FMEAs and Root Cause analysis.
 Coordinating with QA and compliance team for generating CAPAs for equipments and process failure.
 Recordkeeping, sanitization and maintenance of Purified (De-ionized) Water System
  Assess revalidation requirements to ensure continuous compliance of regulatory requirements
 Assist in evaluation of failures and out of specification results impacting compliance with quality, safety and
other design requirements.
 Assist with investigations and FDA inspections.
 Assist with corrective actions and preventive actions.
 Review FDA deficiencies and commitments

Selected Contributions
 Established a preventive maintenance schedule, ensuring optimal equipment operation without costly
downtime.
 Significantly reduced waste and end-to-end production time by levering expertise with Statistical Process
control (SPC) methodology.

Stevens Pharmaceutical Research Center Lab Hoboken, NJ

Validation Engineer August 2014 – December 2014

 Developed and reviewed VMP, protocol, validation summary report and master batch record.
 Executed IQ, OQ and PQ for different laboratory scale equipment.
 Prepared and maintained logbook according to cGMP standards.
 Prepared and validated spreadsheet for content uniformity.
 Developed and validated swab sampling method using TOC analyzer.
 Executed temperature mapping of oven using omega data logger.
 Developed and validated method for dissolution and content uniformity.
 Carried out Cleaning Validation Project.

CORE COMPETENCIES

 Knowledge of CFR (21 CFR part 210, 211 and 11, 820), ICH guidelines, cGMP and GLP
 Know how to develop Risk Assessment, Root Cause Analysis, DoE, QbD, Fish bone diagram, process mapping.
 Detailed knowledge of Word, Excel, PowerPoint, Minitab, Quality management software, M-File (Electronic
Document Management System), MS project.
 Attended and having Certificate for cGMP training, Validation and Regulatory Affairs and Pharmaceutical
Manufacturing Practices.