Engineer

As a dedicated Qualification Professional, you will be responsible for overseeing the execution of Pre-Factory Acceptance Tests (Pre-FAT), Factory Acceptance Tests (FAT), and Site Acceptance Tests (SAT) in accordance with established test protocols. Your primary role will involve engaging directly with customers to ensure adherence to test specifications and securing necessary documentation and approvals during FAT at our facilities and SAT at customer locations. You will be expected to conduct thorough testing and troubleshooting of systems, including SCADA, to ensure optimal performance. Additionally, you will monitor and address Non-Conformance Reports (NCRs) arising during Pre-FAT, FAT, and SAT stages. It is important to demonstrate a strong understanding of regulatory standards such as GMP, GEP, GAMP, and ISPE, and apply this knowledge in practice. Your responsibilities will also include guiding customers through FAT processes, working collaboratively on projects involving multiple customers, and engaging in the continuous review and improvement of internal processes to enhance efficiency and quality. Documenting all testing procedures in accordance with standardized protocols and contributing to the refinement of internal processes will be essential aspects of your role. To qualify for this position, you should have a Bachelor's degree in science, engineering, or a related field relevant to the biopharmaceutical industry. A minimum of 3-5 years of experience in the qualification and commissioning of bio pharmaceutical equipment is required. You should possess solid technical and process engineering knowledge, including proficiency in interpreting technical drawings and standards. Being organized, detail-oriented, and methodical in your approach to tasks, as well as skilled in prioritizing and managing daily responsibilities effectively, are key qualities for success in this role. Exceptional written and verbal communication abilities, a commitment to establishing positive relationships with internal and external stakeholders, and proficiency in English and the local language are highly desirable skills. Overall, as a Qualification Professional, you will play a crucial role in ensuring the successful execution of testing procedures, maintaining regulatory compliance, and contributing to the continuous improvement of processes to uphold quality standards within the company.,