Application and Compliance Engineer (CSV Engineer) and Project Coordinator

• Oct 2020 - Present

• Working as a technical SME and project coordinator for validation and deployment of GMP Electronic Logbook Management (e-logbook) system in Pfizer Newbridge, Ireland. • Working in a Project Management team to manage the project for the deployment of P-LOG in Pfizer Newbridge, Ireland • Support activities include but not are limited to the preparation of User requirement specification (URS), Validation plan, SOPs, Change control, User access review (UAR), Periodic review, and Data integrity assessment. • Conduct Audit trail review for Computerised Systems • Performing and reviewing project lifecycle documentation and SOPs as per GDP requirements • Development of GxP Computerised Systems Lifecycle documents across the entire validation lifecycle for all types of GxP assets e.g. Lab. Automation. Business and Equipment systems Provide assistance where required with the preparation/testing of validation protocols and all associated documentation for GxP Computerised Systems. • Review/Approval of all GxP Computerised Systems Validation Documentation. Administration of GAMP lifecycle across projects. Adhere Quality Management System (QMS) Policies and Procedures. • Involve in the testing of the system and have experience with SpiraPlan. • Experienced in creating and executing test scripts. • Support an Audit preparation and was part of the Audit Team Show less

Bioprocess Trainee

• Feb 2020 - Feb 2020

Carried out experiments in a world-class bioprocessing pilot plant NIBRT which provides research solution for the bioprocessing industry which includes. 1.Layout of a biopharmaceutical manufacturing facility and utilities - Purified water, air, cleaning solutions and clean steams. 2. Bioreactor SIP 3. Perform ultrafiltration and defiltration 4 .Studied Disposable technology 5. Perform cleaning and sterilization ( COP/SOP) Practical 6. Studied Column packing and testing Chromatography column efficiency 7. Execute Filter integrity testing 8.Perform experiment of CHO Cell culture Show less

Process Engineer

• May 2019 - Jun 2019

1.Calculate all process calculationsfor this agro industryand quantitative aspects of bio-products and support manufacturing unit. 2.Responsible for the formation of bio pesticides, production planner scheduler, manufacturing/ calibration techniques. 3.Ensuring all the process validation protocol should implied and producing report based on it. 4. Analyzing data and discuss with other team members for process development. 1.Calculate all process calculationsfor this agro industryand quantitative aspects of bio-products and support manufacturing unit. 2.Responsible for the formation of bio pesticides, production planner scheduler, manufacturing/ calibration techniques. 3.Ensuring all the process validation protocol should implied and producing report based on it. 4. Analyzing data and discuss with other team members for process development.

Assistant Engineer

• Nov 2018 - Apr 2019

1. Perform analytic techniquesin the R&D unit and optimize data for manufacturing unit. 2. Worked with customers to comply with ISO requirements, discuss requirement of with customers and worked on it and reviewing documentation related to technology transferred process. 3.Use existing procedures to perform daily hands-on calibration work as well as process validation, ensuring calibration and validation are performed as scheduled and defined in SOPs. 1. Perform analytic techniquesin the R&D unit and optimize data for manufacturing unit. 2. Worked with customers to comply with ISO requirements, discuss requirement of with customers and worked on it and reviewing documentation related to technology transferred process. 3.Use existing procedures to perform daily hands-on calibration work as well as process validation, ensuring calibration and validation are performed as scheduled and defined in SOPs.

Quality Engineer

• Jun 2018 - Oct 2018

1.Worked as a biotechnology engineer within a wider team of quality professionals with the overall aim of maintaining quality of the final product such as bio fertilizers and micronutrients. 2.Specific worked on the quality risk management systems of the manufacturing process to assure quality for process and validation of final product. 1.Worked as a biotechnology engineer within a wider team of quality professionals with the overall aim of maintaining quality of the final product such as bio fertilizers and micronutrients. 2.Specific worked on the quality risk management systems of the manufacturing process to assure quality for process and validation of final product.

Internship Trainee in API section

• Jun 2017 - Jun 2017

1.Worked closely with R&D Scientists to develop, and test scale-up processes for new products/processes from lab procedures to high volume manufacturing 2.Learnt how to implement new operating procedures, worked on it and learnt selection of operations for new processes, quality requirements. 3. Gain understanding of cGMP environment and ICH guidelines for implementation of medicinal products. 4.Gained a significant understanding about API capabilities, which are steered by superior chemistry skills, quality- driven and a cost-effective manufacturing process before the formulation of medicine. Show less

Summer Internship

• Jun 2016 - Jun 2016