Filling Operator Lead (6 am-2:30 pm)

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 aseptic 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, which includes semi-automatic loading of glass vials, caps, and seals into manufacturing machinery, semi-automatic unloading of finished product from the manufacturing machinery, 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 as needed and will be the responsible person for the proper operation of the 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

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.
Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
Employee must be able to occasionally lift and/or move up to 50 pounds.
Ability to meet and maintain cleanroom gowning requirements.
Ability to meet and maintain respirator fit-testing requirements.

Nice To Haves

High School Diploma or GED equivalent preferred.
Technical degree and/or some college in a relevant field are a plus.
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.
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.
Performs machine diagnostics and repairs as required.
Programs equipment recipes in support of all filling, lyophilization, and diagnostic procedures.
Attends all training programs as required by Company SOPs, procedures, and policies.
Performs any other tasks/duties as assigned by management.
Embraces the QUALITY culture.