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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 Setup - 2nd shift

Description

SUMMARY OF POSITION

The Setup Operator will prepare the equipment prior to the start of each batch operation in accordance with all SOP’s and quality controls applicable to that operation, making adjustments for size and/or product as necessary. He/she will monitor the equipment during each batch operation to insure that quality and safety are maintained throughout the operation. The Setup Operator will also be responsible for completing all documentation relative to the status of the equipment associated with each batch on which the equipment is used and maintain compliance for all cleaning requirements.

 

ESSENTIAL FUNCTIONS: 

1.  Assemble, disassemble, maintain, and sanitize the production operating equipment as necessary.

2.  Processing components (washing, extracting, rinsing, and siliconizing)

3.  Monitor production equipment while in operation to ensure quality of product.

4.  Ensure that production equipment is safe and that while in operation it is run safely by all personnel.

5.  Complete all necessary documentation regarding the equipment and its operational performance to meet regulatory and cGMP requirements.

6.  Operate an autoclave to sterilize product prior to packaging.

7.  Operate in an ISO5 or lower classified area

 

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. Assist Team Leader in coordinating maintenance activities.
  3. Prevent excess waste of product and/or components by operating the equipment in an efficient manner.
  4. Maintain production schedules.
  5. Work with groups in initiating and implementation of programs such as continuous improvement (Lean) and autonomous maintenance (TPM). 
  6. Other duties as assigned with or without accommodation.
Required Skills & Background

MINIMUM REQUIREMENTS:

 

Education required/ preferred:

High School diploma, GED, or equivalent required

2 year Technical degree preferred

Experience:

2-5 years experience as a Production Set-up Operator or mechanic in a pharmaceutical manufacturing environment (preferred).

Preferred Skills/Qualifications:

  1. Good verbal and interpersonal communication skills
  2. Basic knowledge and use of hand tools
  3. Sound decision making skills
  4. Good math, reading, writing skills
  5. Demonstrated mechanical aptitude
  6. Mental and visual acuity for production of quality product
  7. Strong trouble shooting skills

Skills/Competencies:

1.   Basic computer skills – Microsoft Office package

2.  Ability to lift up to 50 pounds

Other Skills:

Ability to work well in a team environment

 

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

 

  • Report directly to Production Supervisor
  • Fill in as needed on the production line to assist the Production Operators
  • Coordinate with Engineering and Purchasing to procure necessary parts and supplies
  • Work closely with Maintenance to resolve issues with the equipment
     
    WORKING CONDITIONS:
     
  1. Work in areas where special clean room apparel and safety equipment will be required
  2. Standing is required for extended periods of time
  3. Require high degree of manual dexterity, which could be performed under restrictive conditions
  4. Requires flexible hours and short notice overtime
     
    DISCLAIMER:
     
    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.