Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Shaik Pasha

Des Plaines,IL

Summary

Intelligent and Industrial Engineer with extensive experience assessing software systems for alignment with specifications and project goals. Talented at documenting and reporting for accurate recordkeeping. Enthusiastic professional with focus on effectively analyzing test results.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Automation/Validation Engineer

Pfizer
Kalamazoo, MI
02.2021 - Current
  • Documented entire validation process, noting changes or alterations completed.
  • Analyzed pre-release software titles for compliance with User Requirement Specifications (URS), referring any deficits to appropriate personnel.
  • Involved in testing and troubleshooting different kinds of hardware such as Allen Bradley, Siemens and Rockwell Automation Allen-Bradley.
  • Worked on technical documentation as required, doing Software Change Log (SCL) and PMDS (PLC Module Design Specification), considering cGMP and GDP. Participated in development of automation system life cycle documents to meet cGMP requirements(i.e., validation, SOPs, periodic review, and PM).
  • Documented Installation Qualification (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ) Protocols in person, with team and with third-party implementor.
  • Reviewed, identified and remediated legacy CAPAs for proper content (containment, problem investigation, risk assessment, GDP, root cause, action plans).
  • Lead Execution plan with team of 15 for Freeze Dryers.

Manufacturing Engineer

BioMerieux
Hazelwood, MO
10.2021 - 02.2022
  • Worked with cross-functional engineering team (mechanical, electrical, automation) in setup of manufacturing facility.
  • Managed resolution of major equipment breakdowns and quality issues in suites by driving robust root cause analysis (RCA) process
  • Experience in developing, reviewing, approving, writing, and executing start-up and commissioning, SOP, DQ,IQ, OQ, and PQ protocols, and writing final reports. Hands on experience in creating Design History Files (DHF).
  • Having knowledge of good Documentation Practices (GDP) and good Manufacturing Practices (GMP), ECN,
    NCMR and Corrective Actions and preventive Analysis (CAPA), FDA and ISO regulations.
  • Created Assembly Procedures (AP’s) and animated videos using Solid works Composer.
  • Knowledge in 21 CFR, Part 11 Compliance, strong base in Process Validation, Complaint Handling, Test method validation and Equipment Qualification.

Student Intern

National Corn To Ethanol Research Center
Edwardsville, IL
05.2021 - 09.2021
  • Reduced 0.2% moisture content of product by ideally controlling vacuum belt which reduced overall time by 15min.
  • Created and edited Sop’s for Drying and and used lean continuous improvement using Kanban process.
  • Analyze and troubleshoot problems of plant by using PDCA method.
  • Learned and executed work in all areas of plant (Front end, vacuum belt, filter press and dryer) and led team of 10+ people, reported day end Schedule during shift change.

Graduate Teaching Assistant

Southern Illinois University Edwarsville
Edwardsville, IL
01.2021 - 06.2021
  • Evaluated and grade examinations, assignments and record grades for 32 students and worked with professors to monitor each student's development.
  • Scheduled and maintained regular virtual meetings to help students with NX(Unigraphics)software designs.

Education

Master of Science - Industrial Engineering

Southern Illinois University Edwardsville
Edwardsville, IL
08.2021

Bachelor of Science - Mechanical Engineering

Jawaharlal Nehru Technical University Hyderabad
India
04.2019

Skills

  • CATIA V5
  • AutoCAD
  • Ansys(APDL and Workbench)
  • Unigraphics NX
  • SolidWorks
  • Minitab
  • Microsoft office
  • Effective Working Relationships
  • Manufacturing Engineering
  • Quality Management, Design Specifications
  • Depth Perception, Shooting
  • Design Specifications
  • Fixtures
  • Color Vision
  • Manufacturing Processes
  • Cad

Certification

  • ISO 9001 Certified 3D Designing Software's
  • Provisional Patent for spherical Wheel Bike.

Timeline

Manufacturing Engineer

BioMerieux
10.2021 - 02.2022

Student Intern

National Corn To Ethanol Research Center
05.2021 - 09.2021

Automation/Validation Engineer

Pfizer
02.2021 - Current

Graduate Teaching Assistant

Southern Illinois University Edwarsville
01.2021 - 06.2021

Master of Science - Industrial Engineering

Southern Illinois University Edwardsville

Bachelor of Science - Mechanical Engineering

Jawaharlal Nehru Technical University Hyderabad

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Shaik Pasha