Engineer Qualification
Engineer Qualification
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Job Description
We are seeking a dedicated Qualification Professional to oversee the of PreFactory Acceptance Tests (PreFAT) 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 NonConformance Reports (NCRs) arising during PreFAT 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:
Bachelors degree in science engineering or a related field with relevance to the biopharmaceutical industry.
At least 35 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.
About Sartorius
Sartorius is part of the solution in the fight against cancer dementia and many other diseases. Our technologies help translate scientific discoveries into realworld medicine faster so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius/careers
Employment Type
Full-Time
