Filling Setup Operator - 2nd Shift

Laboratoire Guerbet•Raleigh, IL

1d•Onsite

About The Position

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. This is a 2nd shift role.

Requirements

High School Diploma, GED, or equivalent required.
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.
Demonstrate understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.) in an aseptic environment.

Nice To Haves

2-5 years’ experience as a Production Set-Up Operator in a pharmaceutical manufacturing environment preferred.

Responsibilities

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 escalate 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.