Sujalkumar Patel

SUMMARY

A Validation Engineer with experience supporting Cleaning Validation, Equipment Validation, and Process Validation to support global pharmaceutical industries.

Good Project Management skills with experience leading Validation Programs to support cGMP manufacturing operations including aseptic vaccine and biologics production.

Strong technical writing skills with experience authoring standard operating procedures (SOP) and validation protocols for cleaning validation (CV), equipment calibration and qualification (IQ, OQ, PQ), process validation (PV), and computer system validation (CSV).

Lead Equipment Validation and Cleaning Validation projects including Clean-in-Place (CIP) and Steam-in-Place (SIP) studies of Lyophilizer, Nitrogen Tunnels, Pressure Washer, Blast Freezer, Depyrogenation Tunnel, and Vial Washer.

Lead in the Lyophilizer Continuous Improvement Project; executing cleaning validation and sterilization validation studies in vaccine manufacturing areas.

Execute developmental, investigational, and performance qualification (PQ) validation studies; identifying deviations/nonconformances, conducting root cause analysis (RCA), and implementing corrective and preventative actions (CAPA).

Collaborate cross-functionally with Manufacturing, Quality Control, and Process Engineering to ensure safety and compliance within highly regulated areas (cGMP, GLP, FDA, QSR, ISO, and CFR).

Complete Lean Six Sigma Training; experience implementing continuous improvement methodologies to eliminate waste, reduce cost, and enhance product quality and performance.

Utilize MS Project to monitor project schedules, JMP and Minitab for Statistical Process Control (SPC), and MIDAS, e-Doc, Trackwise & M-Files for Electronic Document Management; ensuring accuracy, completeness, and integrity of data.

EXPERIENCE

Sanofi Pasteur 2016 – Present

Validation Lead-II

Lead Equipment Validation and Process Validation Programs to support cGMP pharmaceutical manufacturing operations and process monitoring.

Prepare standard operating procedures (SOP) and validation protocols for equipment calibration and qualification (IQ, OQ, PQ).

Lead Equipment Validation projects including manufacturing filling and packaging lines.

Working in the Visual Inspection group of Manufacturing Technology department to qualify an Automated Inspection machine (Seidenader VI-60-S, PI-30) for Syringes/Vials.

Actively involved in the Tech. Transfer projects and development of vision configuration for new products.

Execute developmental, investigational, and performance qualification (PQ) validation studies; identifying deviations/nonconformances, conducting root cause analysis (RCA), and implementing corrective and preventative actions (CAPA).

Assemble, organize, and analyze data related to visual inspection of sterile parenteral manufacturing processes by using JMP.

Collaborate cross-functionally with Manufacturing, Quality Control, and Process Engineering to ensure safety and compliance within highly regulated areas (cGMP, FDA, QSR).

Utilize MS Project to monitor project schedules, JMP and Minitab for Statistical Process Control (SPC), and Electronic Document Management Systems; ensuring accuracy, completeness, and integrity of data.

Merck 2014 – 2016

Validation Engineer

Lead Cleaning Validation, Equipment Validation, and Process Validation Programs to support cGMP pharmaceutical manufacturing operations including aseptic vaccine production.

Author validation protocols for cleaning validation (CV), equipment calibration and qualification, and process validation (PV).

Lead Equipment Validation and Cleaning Validation projects including Clean-in-Place (CIP) and Steam-in-Place (SIP) studies of Lyophilizer, Nitrogen Tunnels, Pressure Washer, Blast Freezer, Depyrogenation Tunnel, and Vial Washer.

Lead in the Lyophilizer Continuous Improvement Project; executing cleaning validation and sterilization validation studies in vaccine manufacturing areas.

Ensure product quality through robust validation testing and process monitoring.

Conduct inspections; collection of rinse water, swab, Sodium and Bioburden samples.

Execute developmental, investigational, and performance qualification (PQ) validation studies.

Resolve technical issues encountered during study executions.

Prepare validation final reports and raw data file packages.

Schedule Lock Out Tag Out (LOTO) testing to ensure safety.

Collaborate cross-functionally with Manufacturing, Quality Control, and Process Engineering to ensure safety and compliance within highly regulated areas (cGMP, GLP, FDA, QSR, ISO, and CFR).

Utilize XpertVal, XpertLogger, ValProb & Ellab logger to perform sterilization validation studies in vaccine manufacturing areas, Minitab for Statistical Process Control (SPC), and Electronic Document Management Systems; ensuring accuracy, completeness, and integrity of data.

Stevens Pharmaceutical Research Center 2013 – 2014

Validation Specialist / Cleaning Validation Engineering

Author validation protocols for cleaning validation (CV), equipment qualification (IQ, OQ, PQ), and process validation (PV).

Write standard operating procedures (SOP), validation master plans (VMP), master batch records, and risk analysis reports.

Lead Equipment Validation and Cleaning Validation projects for Autoclaves, Ovens, and Mixers.

Execute developmental, investigational, and performance qualification (PQ) validation studies; identifying deviations/nonconformances, conducting root cause analysis (RCA), and implementing corrective and preventative actions (CAPA).

Prepare and maintain logbook according to GMP standards.

Develop and validate swab sampling method using TOC analyzer for cleaning validation.

Conduct temperature mapping of an Oven using Omega Data Logger.

Support other cleaning validation projects related to Automation of GMP activities.

Conduct solvent interference study using Total Organic Carbon Analyzer.

Method development and validation of recovery of water insoluble compound (Theo bromine) using Total Organic Carbon analyzer.

Use HPLC analyzer to identify Theo bromine content.

Perform Quality Audit for final products.

Improve current formulas and processes using Lean Six Sigma.

Perform statistical Process Control (SPC) and use quality tools like DoE (Design of Experiment), Process Capability, ANNOVA, t-test, Accuracy and Precision, Process Control Plan, Change Control, Gage Bias- Linearity Study, and Gage R&R using Minitab17 statistical software.

Perform projects considering PAT, QbD, and Six Sigma concepts to reduce validation effort and increase product quality with compliance with QSR, ISO, and GMP.

Use DOE method to develop process and perform Monte-Carlo’s simulation to produce robustness.

Develop FMEA, CAPA, and Cause and Effect Diagram for design, process, equipment, and risk analysis.

Vital Formulation 2011 – 2012

Quality Engineering Associate

Perform Quality Control Testing; identifying deviations/nonconformances, conducting root cause analysis (RCA), and implementing corrective and preventative actions (CAPA).

Conduct in-process inspections of various tablet parameters such as appearance, weight variation, hardness, thickness, friability, disintegration, and dissolution at compression stage.

Work in ISO 5 area and assist in aseptic transfer, inoculation, sterilization of media, and culture.

Check quality of product and improve process development steps.

Review and audit documentation such as quality policies.

Approve batch records and protocols.

Manage calibration schedules of instruments and equipment.

EDUCATION

Stevens Institute of Technology

Master's Degree, Pharmaceutical Sciences, Pharmaceutical Manufacturing Engineering & Validation

The Oxford College of Pharmacy

B. Pharma, Pharmacy

Course Work: Validation & Regulatory affairs in pharmaceuticals, Project Management fundamentals, Regulation & Compliance in Pharmaceuticals, Quality in Pharmaceutical manufacturing, Lean Six Sigma in Pharmaceutical Industry, Manufacturing & Packaging of Pharmaceutical OSD Products, Design and Management of Aseptic Pharmaceutical Manufacturing Processes, Engineering Economics & Cost Analysis, Contemporary Concept in Pharmaceutical Validation, Good Manufacturing Practice in Pharmaceutical Facilities Design.

SKILLS

Compliance: cGMP, GLP, FDA, QSR, ISO, CFR (21 CFR parts 210,211, 11, 820, 54, 58), EPA, GCP requirements and ICH guidelines.

Quality Tools: Lean Manufacturing, Documentation, Process capability, CAPA, Fish bone diagram, Audit, FMEA, Root Cause Analysis, Pareto Charts, Histogram, Cause and effect analysis, Process Mapping, Various tools like Poke yoke, Kaizen.

Laboratory Skills: Evaluation of Pharmaceutical product, Tablets punching machine, dissolution & disintegration testing and apparatus, Thin layer chromatography, Gas Chromatography, Kaye validator, Lab notebook, Swabbing and Spiking, TOC analysis, Swab Sampling, Spiking method, CIP, SIP.

Software: Minitab 17 (Statistical Process Control), M-Files (Electronic Document Management System), MS Project, MS Excel, MS Word, MS Power Point, Spreadsheet.

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