Filling Operator

Filling Operator Raleigh, NC Job Details Full-time 14 hours ago Qualifications Computer operation Pharmaceutical regulatory compliance Computer literacy Safety standards in production High school diploma or GED Manufacturing standard operating procedures Math Disinfection procedures Quality control documentation Continuous improvement Decision making Batch records Pharmaceutical plant experience Quality standards in production Cleanroom Mathematical aptitude Productivity software 1 year Aseptic technique Hand tools Communication skills Implementing lean manufacturing processes Entry level Electric pallet jack FDA regulations Full Job Description 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 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients. Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis. Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

WHAT WE ARE LOOKING FOR

The Filling Operator is responsible for operating 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 Operator will also be responsible for completing all necessary documentation related to the manufacturing process while adhering to cGMP and GDP guidelines.

YOUR ROLE

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. Performs other duties as assigned by management

Department Specific/Non-Essential Functions:

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. Performs other duties as assigned.

YOUR BACKGROUND

Education, Experience, and/or

Skill:

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.

Physical Requirements:

Ability to stand for extended periods of time. Must be able to continuously lift a minimum of 50 Ibs. 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.

Cognitive Requirements:

Ability to read and understand military time is required. Requires a high degree of manual dexterity to perform tasks using aseptic techniques under restrictive or controlled conditions. Strong verbal and interpersonal communication skills. Excellent reading comprehension and attention to detail for interpreting batch records and SOPs. Strong mathematical aptitude for accurate measurements and calculations. Mental and visual acuity for production of quality product. Highly skilled in problem-solving and diagnostic abilities. Demonstrates initiative and sound decision making while working effectively both independently and as part of a team. Demonstrates strong attention to detail in all tasks to ensure accuracy and compliance.