Engineer Qualification

We are seeking a dedicated Qualification Professional to oversee the execution of Pre-Factory Acceptance Tests (Pre-FAT), Factory Acceptance Tests (FAT), and Site Acceptance Tests (SAT) in accordance with established test protocols. The successful candidate will engage directly with customers, ensuring adherence to test specifications and securing necessary documentation and approvals during FAT at our facilities and SAT at customer location.

Key Responsibilities:

• Conduct thorough testing and troubleshooting of systems, including SCADA, to ensure optimal performance.
• Monitor and address Non-Conformance Reports (NCRs) arising during Pre-FAT, FAT, and SAT stages.
• Demonstrate a strong understanding of regulatory standards such as GMP, GEP, GAMP, and ISPE, and apply this knowledge in practice.
• Guide customers through FAT processes, ensuring a transparent and satisfactory experience.
• Work collaboratively on projects involving multiple customers, ensuring seamless integration and communication.
• Engage in the continuous review and improvement of internal processes in collaboration with the production team, enhancing efficiency and quality.
• Document all testing procedures in accordance with standardized protocols.
• Contribute to the refinement of intern al processes to uphold our commitment to quality.
• Facilitate smooth interdepartmental coordination to ensure timely project deliverables.
• Participate in ongoing improvement initiatives, demonstrating a proactive approach to enhancing company operations.
• Resolve issues effectively by collaborating with cross functional teams.
• Exhibit strong interpersonal and communication skills, capable of building and maintaining professional relationships.

Qualifications Skills:

• Bachelor’s degree in science, engineering, or a related field, with relevance to the biopharmaceutical industry.
• At least 3-5 years of experience in the qualification and commissioning of bio pharmaceutical equipment.
• Solid technical and process engineering knowledge, including proficiency in interpreting technical drawings and standards.
• Proven ability to develop and follow realistic work plans, setting personal objectives that support company goals.
• Organized and detail oriented, with a methodical approach to tasks.
• Skilled in prioritizing and managing daily responsibilities effectively.
• Exceptional written and verbal communication abilities, with the capacity to represent the company professionally.
• Commitment to establishing and nurturing positive relationships with all internal and external stakeholders.
• Proficiency in English and the local language is highly desirable.