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

American Regent•Hilliard, OH

3d•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. The Team Member will be able to participate in all aspects of the Manufacturing Process, including semi-automatic loading and unloading of product, and set-up/tear-down and line clearances of 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. They will provide direction, training, and mentorship to 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. They will also be able to create and perform parameter setup activities for all manufacturing technologies using the HMI-PLC/SCADA control/data systems and assist in technology transfer from R&D, providing input for 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.
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.