INAM ULLAH
Validation Engineer
Hsinchu City,HSQ
Summary
Enthusiastic Validation Engineer with over 3.5 years of cGMP Validation/Qualification experience in the Bio-Pharmaceutical and eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of Validation LifeCycle and training in cGMP. Motivated to learn, grow and excel in Pharmaceutical and Biotech Industry. Good integrity toward jobs and teamwork spirit. Conscientious and attending to details.
Detail-oriented, organized and meticulous employee. Works at fast pace to meet tight deadlines. Enthusiastic team player ready to contribute to company success.
Overview
4
4
years of professional experience
4
4
years of post-secondary education
Work History
Assistant Validation Engineer
Bora Pharmaceuticals
Hsinchu County, HSZ
07.2022 - Current
- Responsible for Computerized System Validation.
- Write, execute, and review Qualification protocol (DQ/IQ/OQ/PQ/RQ), specification documents (URS, FS, DS, FAT/SAT) and Summary report, complying with Good Manufacturing Practices (PIC/S GMP) and Food and Drug Administration (FDA) requirement.
- Preparing SOP and associated records covering Validation lifecycle: Risk Assessments, URS, Qualification Protocols, Reports, Protocol Execution.
- Created plans and communicated deadlines to complete projects on time.
- Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork.
- Improved operations through consistent hard work and dedication.
Assistant Validation Engineer
EDEN Biologics Inc
Hsinchu County, HSZ
01.2019 - 06.2022
- Responsible for Computerized System Validation.
- Data Integrity risk assessment of computerized system.
• Responsible for HVAC System Qualification.
• Write, execute, and review Qualification protocol (DQ/IQ/OQ/PQ/RQ), specification documents (URS, FS, DS, FAT/SAT) and Summary report, complying with Good Manufacturing Practices (PIC/S GMP) and Food and Drug Administration (FDA) requirement.
• Handle non-conformance investigation, like deviation and corresponding CAPAs.
• Familiar with Bio-safety Cabinet, Laminar Flow qualification.
• Familiar with handling of test instruments like Kaye Validator, Data Loggers and Paperless Recorder.
• Preparing SOP and associated records covering Validation lifecycle: Risk Assessments, URS, Qualification Protocols, Reports, Protocol Execution. - Learned new skills and applied to daily tasks to improve efficiency and productivity.
- Exceeded goals through effective task prioritization and great work ethic.
- Proved successful working within tight deadlines and fast-paced atmosphere.
Assosiate Validation Engineer
Wilson's Pharmaceuticals
Islamabad, ISL
02.2018 - 09.2018
- Write, execute, and review Qualification protocol (DQ/IQ/OQ/PQ/RQ), specification documents
- Learned new skills and applied to daily tasks to improve efficiency and productivity.
Education
Bachelor of Science - Computer Engineering
Pir Mehr Ali Shah Arid Agriculture University
Pakistan 10.2013 - 10.2017
Skills
Data interpretation skills
Process Development
Process Control Analysis
Equipment testing and operation
Activity planning and scheduling
Data analysis and assessments
Timeline
Assistant Validation Engineer
Bora Pharmaceuticals
07.2022 - Current
Assistant Validation Engineer
EDEN Biologics Inc
01.2019 - 06.2022
Assosiate Validation Engineer
Wilson's Pharmaceuticals
02.2018 - 09.2018
Bachelor of Science - Computer Engineering
Pir Mehr Ali Shah Arid Agriculture University
10.2013 - 10.2017