Filling Operator - 2nd Shift
About the role
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 for the last 95 years, we continuously innovate. We dedicate 10% of our revenue to Research & Development to improve the diagnosis, prognosis and quality of life of patients. Our values are Achieve, Cooperate, Care and Innovate. Working at Guerbet means being part of a multicultural team of 2,600 people across more than 20 countries and playing a unique role in the future of medical imaging.
Much more than a competitive salary, we offer continued personal development. When you join Guerbet, you: are choosing a global leader with recognized expertise in diagnostic and interventional imaging; are joining our 2,820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world; are joining a company where we value diversity of talents coming from various horizons. We #Innovate #Cooperate #Care #Achieve at Guerbet.
Responsibilities
- Operate and monitor filling equipment to ensure efficient and accurate production.
- Monitor production equipment while in operation to ensure quality of product.
- Perform cleaning and sanitization of aseptic areas using approved disinfectants and techniques to maintain sterile conditions.
- Maintain strict adherence to aseptic techniques during all operations, including gowning, material transfer, and interventions with controlled environments.
- 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 a 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.
- Prevent excess waste of product and/or components by operating the equipment in an efficient manner.
- Collaborate with Engineering, Validation, and other departments initiating and implementing programs such as Continuous Improvement (Lean and 5S) and Total Productive Maintenance.
- Cross-training to perform tasks and roles outside of the primary responsibilities.
- Perform other duties as assigned by management.
Qualifications
- High School diploma, GED, or equivalent required.
- 1-2 years' experience as a Production 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.
Requirements
- Ability to stand for extended periods of time.
- Must be able to continuously lift a minimum of 50 lbs.
- Ability to operate an electric pallet jack.
- Must be physically able to wear full aseptic gowning, including gloves, mask, and other protective gear, for extended periods while working in a controlled cleanroom environment