Filling Setup Operator - 2nd Shift

At Guerbet, we build lasting relationships so that to enable people to live better
. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve
, Cooperate
, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

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The Filling Setup Operator is responsible for preparing the manufacturing equipment to produce pharmaceutical products in an aseptic environment in accordance with company standard operating procedures. This position will monitor the equipment during each batch operation to ensure that quality and safety are maintained throughout the manufacturing process. The Filling Setup Operator will also be responsible for completing all necessary documentation related to the manufacturing process while adhering to cGMP and GDP guidelines.

The Filling Setup Operator operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

• Set up and configure filling equipment for specific products, ensuring proper calibration and compliance with Standard Operating Procedures (SOPs) and GMP standards.
• Disassemble the filling equipment as necessary.
• Troubleshoot minor mechanical issues and elevate complex problems to maintenance as needed to ensure smooth operations.
• Operate autoclave equipment for sterilization and filling processes.
• Monitor and adjust filling equipment to ensure efficient and accurate production.
• Perform environmental monitoring and in-process checks to ensure compliance with regulatory requirements.
• Perform cleaning and sanitization of clean room areas using approved disinfectants using aseptic techniques to maintain sterile conditions.
• Maintain strict adherence to aseptic techniques during all operations, including gowning, material transfer, and interventions in clean rooms.
• Understand and apply principles of sterility assurance, including proper handling of sterile components and monitoring of aseptic conditions.
• Demonstrate understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.) in an aseptic environment.
• Accurately complete all documentation including but not limited to batch records, logbooks, and deviation reports in compliance with cGMP and data integrity requirements.
• Ensure high level of safety, quality, and productivity to maintain reliable supply of products to patients.
• Promptly report and assist in investigation of any contamination events or deviations.
• Comply with departmental objectives including improving safety and performance, reducing deviations, and training compliance.
• Performs other duties as assigned by management.

• Prevent excess waste of product and/or components by operating the equipment in an efficient manner.
• Collaborate with Engineering, Validation, and other departments in initiating and implementing programs…