Filling Setup Operator

About the role

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.

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.
• 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.

Requirements

• 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.

Qualifications

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

Skills

• 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.

Benefits

At Guerbet, we provide continued personal development opportunities. Join us and:

• Be part of a global leader with recognized expertise in diagnostic and interventional imaging.
• Work alongside 2,820 collaborators dedicated to improving the quality of life for patients worldwide.
• Join a company that values diversity and inclusivity, fostering a culture of innovation, cooperation, care, and achievement.

Pay

Competitive salary offered.

Schedule

Full-time position.

Contact

To learn more about Guerbet and this opportunity, visit www.guerbet.com. For career inquiries, please email careers@guerbet.com or call +19843443717.