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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Production Filling Operator - 2nd Shift

Summary of Position

 

The operator’s responsibilities include filling and inspecting of terminally sterilized and aseptically produced pharmaceutical drugs in accordance with current Good Manufacturing Practices.

ESSENTIAL FUNCTIONS: 

  1. Operate filling equipment and handle product within all applicable SOPS, cGMPs, etc.
  2. Operate equipment within the validated parameters.
  3. Inspect product to maintain quality standards; perform quality control duties, i.e. sampling of product and environment
  4. Follow and maintain documentation records, accountability of solution and units throughout the production process.
  5. Check and verify components.
  6. Clean/sanitize production areas and equipment.
     
    DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
  1. Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment.  Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk.  Report all safety and/or environmental incidents to management immediately
  2. Special projects:  training required for returned goods, reclaim and off-line projects.
  3. Other duties as assigned with or without accommodation.

Minimum Requirements

 

Education required/ preferred:

High School diploma, GED, or equivalent

Experience:

1-3 years pharmaceutical manufacturing experience within a sterile environment (i.e. ISO 5E or similar)

Preferred Skills/Qualifications:

  • Ability to lift 50 pounds
  • Good math and reading skills
  • Mental and visual acuity for production of and identification of quality product

 

Skills/Competencies:

Good verbal and written communication skills

Other Skills:

Ability to work both on a team and individually

 SPECIFICATIONS:

 Job Knowledge:

Operator must understand and adhere to standard operating procedures (SOP’s) in a pharmaceutical manufacturing environment and be able to apply Good Manufacturing Practices. This position also requires successful completion of the training/certification program. 

Accountability:

  • Responsible for reducing product losses and improving yields.
  • Responsible for quality of product.
  • Responsible for monitoring the process and documenting measurements per SOP.
  • Responsible for compliance with FDA, OSHA, cGMP’s
  • Responsible for participation in all Safety aspects of the plant.
  • Responsible for demonstrating initiative, self-direction and ability to make decisions
  • Responsible for demonstrating and support of company policies
     
    Analytical Requirement:
  • Able to work flexible hours.
  • Requires high degree on manual dexterity, which could be performed under restrictive conditions.
  • Mental and visual accuracy is a demand to produce quality product.
  • Responsible for good verbal and interpersonal skills in communication.
  • Make sound decisions and have good math and reading skills.
     
    Supervisory Responsibility:
  • No direct supervisory responsibility; at time must perform with minimum supervision and able to use good judgment and make appropriate decisions
     
    Staff Responsibility:
    N/A
     
    Monetary Responsibility:
  • Perform job responsibilities in a manner that focuses on quality as well as positive financial results.
     
    Contacts:
  • Daily works with other operators, set-up’s, mechanics and process coordinators.
  • Occasional interaction with cross-functional team member on project teams.
  • Occasional contact with outside vendors.
     
    Essential Elements:
  • Work in areas where special gowning is required.
  • Able to visually inspect containers.
  • Requires continuous lifting of 50-55 lbs. and operate electric jacks.
  • Work in areas where standing or sitting is required for extended periods.