Filling Setup Operator

At Guerbet, we build lasting relationships so that we enable people to live better.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging.
As a pioneer in the field of contrast products for the last 95 years, we continuously innovate.
Achieve, Cooperate, Care, and Innovate are the values ​​that we share and practice.
For more information on Guerbet, go to www.
guerbet.
com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube.
WHAT WE'RE LOOKING FOR: The Filling Setup Operator will prepare the equipment prior to each batch operation according to SOPs and quality controls, adjusting for size and/or product as necessary.
He/she/they will monitor the equipment during each batch operation to ensure that quality and safety are maintained throughout the operation.
The operator will also complete documentation concerning the status of the equipment during each batch maintain compliance for all cleaning requirements.
This position is located at our Raleigh, NC site Monday-Friday, 10pm-6:30am.
YOUR ROLE: - Assemble, disassemble, maintain, and sanitize the production operating equipment as necessary.
- Process components (wash, extract, rinse, and siliconize).
- Monitor production equipment to ensure quality of product and safety of personnel.
- Complete necessary equipment documentation to meet regulatory and cGMP requirements.
- Operate an autoclave to sterilize product prior to packaging.
- Operate in an ISO5 or lower classified area - Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment.
- 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.
- Initiate and implement programs such as continuous improvement (Lean) and autonomous maintenance (TPM) in a team of 10-12 operators.
- Other duties as assigned with or without accommodation.
YOUR BACKGROUND: - High School diploma, GED, or equivalent required - 2-year technical degree (preferred) 2-5 years as a set-up operator or mechanic in a pharmaceutical 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 troubleshooting skills - Basic computer skills – Microsoft Office package - Ability to lift up to 50 pounds