Filling Setup Operator

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.

For more information on Guerbet, go to  and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

WHAT WE ARE LOOKING FOR

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. 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.

YOUR ROLE

• 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 adjustfillingequipmentto ensure efficient andaccurateproduction.
• 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, includinggowning, material transfer, and interventions in clean rooms.
• Understand and apply principles of sterility assurance, including properhandlingof 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 withcGMP and data integrity requirements.
• Ensurehighlevel of safety, quality, and productivity tomaintainreliable supply of products to patients.

YOUR BACKGROUND

Education, Experience, and/or Skill:

• High School Diploma, GED, or equivalent required.
• 2-5 years’ experience as a Production Set-Up Operator in a pharmaceutical manufacturing environment preferred.
• Knowledge of basic computer skills and Microsoft Office.
• Skilled in the proper handling and use of basic hand tools for routine adjustments and minor maintenance.
• Strong knowledge of aseptic processing, cleanroom standards, and sterile techniques.

Physical Requirements:

• Ability to stand for extended amounts of time.
• Must be able to continuously lift a minimum of 50
  
  Ibs.
• Ability tooperatean electric pallet jack.
• Must be physically able to wearfull clean room gowning, including gloves, mask, and other protective gear, for extended…