Filling Setup Operator - 1st Shift (Raleigh, US)

Guerbet; Raleigh (NC); Presencial; USD 30 000 - 39 000; Tempo integral

Resumo da oferta

Guerbet is hiring a Filling Setup Operator for 1st shift in the Raleigh, NC area. The role involves preparing filling lines for sterile pharmaceutical products, ensuring GMP compliance, and maintaining strict aseptic conditions in a controlled environment.

The successful candidate will set up equipment, document batch records, and assist in deviations investigations while coordinating with maintenance and quality teams. Ongoing training and adherence to safety standards are emphasized.

Qualificações

• High School Diploma or GED 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 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 regulatory compliance.
• Perform cleaning and sanitization of clean room areas using approved disinfectants and aseptic techniques.
• Maintain strict adherence to aseptic techniques during all operations, including gowning and material transfer.
• Understand and apply principles of sterility assurance and handling of sterile components.

Conhecimentos

Aseptic processing knowledge

GMP compliance

Documentation & recordkeeping

Basic computer skills

Hand tool handling

Formação académica

High School Diploma or GED

Ferramentas

Microsoft Office

Pallet jack operation

Cleanroom equipment handling

Descrição da oferta de emprego

Filling Setup Operator - 1st Shift

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 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 1st shift position: Mon-Thurs, 5:00 AM to 3:30 PM.

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 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.
• 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 in 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 by management.

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 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 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.

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.

Working Conditions:

• This position will be working in a controlled production environment located at a pharmaceutical manufacturing plant.
• Work in areas where aseptic gowning apparel and PPE will be required.
• Must be able to work flexible hours and accommodate overtime on short notice to meet production demands.

Organizational Relationship/Scope:

• Works daily with other operators, set-ups, mechanics, and process coordinators.

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.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number [phone]