Filling Operator Lead 1st Shift

American Regent•Hilliard, OH

About The Position

The Filling Operator Lead is a senior member of the Manufacturing Team, which manufactures safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The role supports aseptic and sanitary conditions, accurate manufacturing-area and equipment records, production schedules, and company goals. The team member may 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 equipment setup, teardown, and line clearance. Technologies used include HMI-PLC/SCADA-controlled isolation barrier aseptic filling, autoclave sterilization, VHP sterilization, CIP sanitization, SIP sterilization, and lyophilization. In the absence of the Filling Supervisor, the Lead performs, oversees, and provides signatory approval for manufacturing activities. The Lead directs, trains, and mentors junior Filling Operators; is responsible for proper operation of isolators, the lyophilizer, and other manufacturing equipment; and oversees proper use of batch documentation. The role troubleshoots manufacturing processes and equipment, plans and performs minor repairs when needed, configures parameters for manufacturing technologies through HMI-PLC/SCADA systems, and assists with technology transfer from R&D and preparation of Filling Batch Records.

Requirements

High school diploma or GED equivalent preferred; a technical degree and/or some college in a relevant field is a plus.
At least 1 year of experience as a Filling Operator, performing satisfactorily, or 4 years of similar work experience in a related field preferred.
Ability to perform basic mathematical calculations.
Mechanical aptitude and ability to assemble, troubleshoot, and perform minor repairs on manufacturing equipment.
Ability to accept feedback constructively and work in a team-oriented environment.
Ability to read Standard English documents, including SOPs, maintenance schedules, and operating manuals.
Ability to work overtime as needed.
Ability to wear cleanroom/protective gowning and equipment, including goggles, face shields, respirators, and protective gloves.
Must maintain a clean-shaven appearance each working shift to properly wear tight-fitting respirators.
Ability to occasionally lift and/or move up to 50 pounds.
Ability to meet and maintain cleanroom gowning and respirator fit-testing requirements.

Nice To Haves

One year of experience in a training role preferred.
HMI-PLC/SCADA control data system experience is a plus.
Technical degree and/or some college in a relevant field is a plus.

Responsibilities

Gather, stage, and return production materials in support of manufacturing activities.
Assist team members with equipment assembly, cleaning, and storage.
Maintain the cleanliness of manufacturing equipment and areas.
Ensure equipment and supply inventories are maintained and available in accordance with production schedules.
Ensure that only approved materials, equipment, documentation, and procedures are used.
Ensure personnel do not perform tasks without accurate and approved training records.
Staff filling-line operating stations for filling, stoppering, and capping operations, and offload finished product.
Ensure proper QC sampling techniques and procedures are followed and samples are delivered promptly to the QC laboratory.
Perform or oversee manufacturing-process activities and provide signatory approval in the Filling Supervisor’s absence.
Direct, train, and mentor junior Filling Operators as needed.
Take responsibility for the proper operation of isolators, the lyophilizer, and other manufacturing equipment, and for proper use of batch documentation.
Troubleshoot manufacturing processes and equipment and plan or perform minor repairs as needed.
Create and perform parameter setup activities for manufacturing technologies using HMI-PLC/SCADA control and data systems.
Assist with technology transfer from R&D and provide input and assistance in creating Filling Batch Records.
Attend training programs required by company SOPs, procedures, and policies.