Filling Setup Operator M/F (30689)

Laboratoire Guerbet•Raleigh, IL

3d•Onsite

About The Position

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.

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.
Ability to stand for extended amounts 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 clean room gowning, including gloves, mask, and other protective gear, for extended periods while working in a controlled cleanroom environment.
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

Nice To Haves

2-5 years’ experience as a Production Set-Up Operator in a pharmaceutical manufacturing environment preferred.
Strong knowledge of aseptic processing, cleanroom standards, and sterile techniques.

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.