Filling Setup Operator - 2nd Shift

Guerbet; Raleigh (NC); Híbrido; USD 52.000 - 66.000; Jornada completa

Descripción de la vacante

Guerbet is seeking a Filling Setup Operator to prepare manufacturing equipment for pharmaceutical products in an aseptic environment, ensuring quality and safety on every batch.

The role requires SOP and GMP adherence, documentation, and environmental monitoring, with a 2nd shift schedule (Mon-Thu, 3:00pm–1:30am) and OT as needed. Join Guerbet to contribute to life-improving imaging solutions globally.

Formación

• 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.

Responsabilidades

• Set up and configure filling equipment for specific products, ensuring proper calibration and compliance with SOPs and GMP standards.
• Disassemble the filling equipment as necessary.
• Troubleshoot minor mechanical issues and elevate 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 regulatory compliance.
• Perform cleaning and sanitization of clean room areas using approved disinfectants and aseptic techniques.
• Maintain aseptic techniques during gowning, material transfer, and interventions in clean rooms.
• Understand and apply cGMP and FDA/EMA guidelines in an aseptic environment.
• Accurately complete batch records, logbooks, and deviation reports in compliance with cGMP and data integrity.

Conocimientos

Filling equipment setup

Equipment disassembly

Troubleshooting

Autoclave operation

Aseptic techniques

Gowning procedures

cGMP compliance

Documentation

Environmental monitoring

Microsoft Office

Hand tools

Educación

High School Diploma or GED

Herramientas

Autoclave equipment

Descripción del empleo

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 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on LinkedIn, Twitter, Instagram and YouTube

WHAT WE ARE LOOKING FOR

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.

This is a 2nd shift position. Monday to Thursday, 3:00pm to 1:30am with occasional OT to meet business demand.

YOUR ROLE

• 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 elevate complex problems to maintenance as needed to ensure smooth operations.
• Operate autoclave equipment for sterilization and filling processes.
• Monitor and adjustfillingequipmentto ensure efficient andaccurateproduction.
• 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, includinggowning, material transfer, and interventions in clean rooms.
• Understand and applyprinciples of sterility assurance, including properhandlingof sterile components and monitoring of aseptic conditions.
• Demonstrateunderstanding ofCurrent Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.)in an aseptic environment.
• Accurately complete all documentation includingbut not limited to batch records, logbooks, and deviation reports in compliance withcGMP and data integrityrequirements.
• Ensurehighlevel of safety, quality, and productivity tomaintainreliable supply of products to patients.

YOUR BACKGROUND

Education, Experience, and/or Skill:

• 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 handlingand 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 amounts of time.
• Must be able to continuously lift a minimum of 50Ibs.
• Ability tooperatean electric pallet jack.
• Must be physically able to wearfull clean room 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.
• Strongverbal and interpersonal communication skills.
• Excellent reading comprehension and attention to detail for interpreting batch records and SOPs.
• Strong mathematical aptitude foraccuratemeasurements and calculations.
• Mental and visual acuity for production of quality product.
• Highly skilled in problem-solving anddiagnosticabilities.
• 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

Reason to join US

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 2820 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 horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.