Job description
Guerbet is a human-scale company that aims to become a new global leader in medical imaging.Pioneer in contrast media with 90 years' experience, Guerbet is the only pharmaceutical group dedicated to medical imaging worldwide, with a presence in almost 80 countries via a network of subsidiaries and distributors.
The company offers a comprehensive range of CT scan, Cath Lab, Magnetic Resonance Imaging (MRI) and Interventional Radiology and Theranostic (IRT) products, along with a range of injectors and related medical devices to improve patients' diagnosis, prognosis and quality of life.
More than 60,000 health professionals rely on Guerbet's contrast agents. Advancing in innovation solutions, the diagnosis of major diseases (cardiovascular diseases, cancers, diseases of the central nervous system) and interventional radiology while reconciling efficacy and cost containment, are at the heart of Guerbet's mission.
Our Need:
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. This is a day shift position on a 2-3-2 schedule from 5:00am - 5:30pm.
Your Role:
- Assemble, disassemble, maintain, and sanitize the production operating equipment as necessary.
- Monitor production equipment while in operation to ensure quality of product.
- Ensure that production equipment is safe and that while in operation it is run safely by all personnel.
- Complete all necessary documentation regarding the equipment and its operational performance to meet regulatory and cGMP requirements.
- Run Autoclave to sterilize product prior to packaging.
- 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.
- Assist Team Leader in coordinating maintenance activities.
- Prevent excess waste of product and/or components by operating the equipment in an efficient manner.
- Maintain production schedules.
- Work with groups in initiating and implementation of programs such as continuous improvement (Lean) and autonomous maintenance (TPM).
- Other duties as assigned with or without accommodation.
- High School diploma, GED, or equivalent required
- 2 year Technical degree preferred
- 2-5 years experience as a Production Set-up Operator or mechanic in a pharmaceutical manufacturing environment (preferred).
- Good verbal and interpersonal communication skills
- Basic knowledge and use of hand tools
- Sound decision making skills
- Good math, reading, writing skills
- Demonstrated mechanical aptitude
- Mental and visual acuity for production of quality product
- Strong trouble shooting skills
- Basic computer skills – Microsoft Office package
- Ability to lift up to 50 pounds
- Ability to work well in a team environment
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