Filling Operator Lead 1st Shift

American Regent, Inc. • Hilliard, OH

4d • Onsite

About The Position

This position is a senior member of the Manufacturing Team, responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The Manufacturing Team ensures asepsis and sanitary conditions are maintained, that appropriate manufacturing area and equipment records are neat and accurate, and that safe, effective, and professional behavior is displayed at all times. In conjunction with Production Management, the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company goals. The Team Member will be able to participate in all aspects of the Manufacturing Process, including semi-automatic loading of glass vials, caps, and seals into manufacturing machinery, semi-automatic unloading of finished product, and the set-up/tear-down and line clearances of the manufacturing equipment. The manufacturing technology utilized includes HMI-PLC/SCADA controlled Isolation Barrier Aseptic Filling, Autoclave Sterilization, VHP Sterilization, CIP Sanitization, SIP Sterilization, and Lyophilization. The Senior Team Member (Lead) will be able to perform, oversee, and provide signatory approval of all activities associated with the manufacturing process in the absence of the Filling Supervisor. The Senior Team Member will provide direction, training, and mentorship to all junior Filling Operators and will be responsible for the proper operation of isolators, the lyophilizer, and all other manufacturing equipment, as well as the proper use of batch documentation. The Senior Team Member will be able to troubleshoot most manufacturing processes and equipment, and where necessary, plan and perform minor repairs during setup and operations. The Senior Team Member will be able to create and perform parameter setup activities for all manufacturing technologies using the HMI-PLC/SCADA control/data systems and will assist in technology transfer from R&D and provide input in creating Filling Batch Records.

Requirements

• High School Diploma or GED equivalent preferred.
• At least 1 year as a Filling Operator, having performed at a satisfactory level or 4 years similar work experience in a related field preferred.
• 1-year experience in a training role preferred.
• Ability to perform basic mathematical calculations.
• Possesses mechanical aptitude with the ability to assemble, troubleshoot, and perform minor repairs on manufacturing equipment.
• Ability to take feedback constructively and function in a team-oriented work environment.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules, and operating manuals.
• Ability to work overtime as needed.

Nice To Haves

• Technical degree and/or some college in a relevant field are a plus.
• HMI-PLC/SCADA control data system experience is a plus.

Responsibilities

• Gathers, stages, and returns production materials in support of manufacturing activities.
• Assists team members with equipment assembly, cleaning, and storage as required to support manufacturing.
• Maintains cleanliness of manufacturing equipment and areas as required to support manufacturing activities.
• Ensures equipment and supply inventories are maintained and available for use in accordance with production schedules.
• Ensures only approved materials and equipment are utilized at all times.
• Ensures that personnel do not perform tasks for which they do not have accurate and approved training records.
• Ensures that only approved documentation and procedures are utilized at all times.
• Staffs filling line operating stations in support of filling, stoppering, and capping operations, and will offload finished product.
• Ensures proper QC sampling techniques and procedures are utilized and ensures timely delivery of samples to the QC laboratory.
• Ability to perform machine diagnostics and repairs as required.
• Ability to program equipment recipes in support of all filling, lyophilization, and diagnostic procedures.
• Attends all training programs as required by Company SOPs, procedures, and policies.
• Perform any other tasks/duties as assigned by management.
• Embrace the QUALITY culture.

Benefits

• Supporting patient health and enhancing the quality of life for animals are our guiding principles.
• Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables.
• American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer.
• For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada.
• For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today.
• For over 30 years, we have supplied the leading joint health products for horses and dogs.
• We have locations in New York, Ohio, and California and sales territories nationwide.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED