Filling Operator - 2nd Shift

Guerbet; Raleigh (NC); On-site; USD 36,000 - 54,000; Full time

Job summary

Guerbet, based in Raleigh, NC, seeks a Filling Operator to operate aseptic filling equipment and maintain product quality in a cGMP environment. You will monitor equipment, complete batch records, and ensure sanitation and sterility throughout the manufacturing process.

Requirements include a high school diploma and 1–2 years of pharmaceutical production experience; strong aseptic and cleanroom knowledge is essential; the role is 2nd shift with potential for growth within a global leader in

Qualifications

• 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.

Responsibilities

• 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
• 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.

Skills

Aseptic processing

Cleanroom standards

Sterile techniques

Manual dexterity

Math aptitude

Communication skills

Education

High School diploma / GED

Tools

Microsoft Office

Hand tools

Job description

At Guerbet, we build lasting relationships so that to enable people to live better. This isOur 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,CareandInnovateare 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 towww.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

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. This is a 2nd shift position.

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.

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.