Packaging Setup Operator - 2nd...

Xtalks; Raleigh (IL); On-site; USD 52,000 - 72,000; Full time

Job summary

Guerbet is seeking a Packaging Setup Operator for 2nd shift in the United States to package pharmaceutical products in compliance with cGMP and GDP. You will operate packaging equipment, complete batch records, and ensure safety, quality, and productivity during each shift.

Candidates should have 2–4 years pharma production experience, a High School Diploma or equivalent, and the ability to use basic hand tools and MS Office. This is a full-time on-site role with growth opportunities.

Qualifications

• High School Diploma, GED, or equivalent required.
• 2-4 years pharmaceutical experience as a Production Operator or Setup Operator in a controlled pharmaceutical manufacturing environment preferred.
• Skilled in the proper handling and use of basic hand tools for routine adjustments and minor maintenance.
• Knowledge of basic computer skills and Microsoft Office.

Responsibilities

• Setup and monitor packaging equipment within validated parameters while performing inspections, verifying components, packaging acceptable units, and maintaining required production documentation.
• Perform routine line setup, changeovers, and equipment adjustments to support scheduled packaging runs.
• Accurately record all downtimes in the GPS systems in real time in support of production tracking.
• Clean and sanitize production areas and equipment in accordance with established procedures and safety standards.
• Demonstrate understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.)
• Demonstrate, uphold, and support all company policies and standards in the performance of daily work responsibilities.
• Accurately complete all documentation, including batch records and logbooks, 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 exceptions.
• Comply with departmental objectives including improving safety and performance, reducing deviations, and training compliance.
• Performs other duties as assigned by management.

Skills

Pharma production experience

Education

High School Diploma, GED, or equivalent

Tools

Microsoft Office

Hand tools

Job description

Packaging Setup Operator - 2nd 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 Packaging 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 Packaging Setup Operator is responsible for the set‑up and operation of manufacturing equipment to package pharmaceutical products 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 packaging process. The Packaging Setup 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: Mon to Thurs 4:45pm to 3:15am.

YOUR ROLE

• Setup and monitor packaging equipment within validated parameters while performing inspections, verifying components, packaging acceptable units, and maintaining required production documentation.


• Perform routine line setup, changeovers, and equipment adjustments to support scheduled packaging runs.


• Accurately record all downtimes in the GPS systems in real time in support of production tracking.


• Clean and sanitize production areas and equipment in accordance with established procedures and safety standards.


• Demonstrate understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.)


• Demonstrate, uphold, and support all company policies and standards in the performance of daily work responsibilities.


• Accurately complete all documentation, including batch records and logbooks, 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 exceptions.


• Comply with departmental objectives including improving safety and performance, reducing deviations, and training compliance.


• Performs other duties as assigned by management.

Education, Experience, And/or Skill

• High School Diploma, GED, or equivalent required.


• 2-4 years pharmaceutical experience as a Production Operator or Setup Operator in a controlled pharmaceutical manufacturing environment preferred.


• Skilled in the proper handling and use of basic hand tools for routine adjustments and minor maintenance.


• Knowledge of basic computer skills and Microsoft Office.

Physical Requirements

• Ability to stand and sit 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 Personal Protective Equipment (PPE).

Cognitive Requirements

• Ability to read and understand military time is required.


• Requires a high degree manual dexterity to carry out packaging activities with precision in a controlled pharmaceutical production setting.


• 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 accuracy is required to produce a quality product


• Highly skilled in problem‑solving and diagnostic abilities.


• Must be able to demonstrate initiative, self‑direction, and have the ability to make sound decisions.


• 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.

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]