Filling Operator Lead 1st Shift

American Regent, Inc.•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 team maintains aseptic and sanitary conditions, accurate manufacturing-area and equipment records, and professional, safe working practices. It also supports other departments and helps maintain production schedules and meet company goals. Team members participate in all aspects of manufacturing, including semi-automatic loading of vials, caps, and seals into machinery; unloading finished product; and equipment setup, teardown, and line clearance. The manufacturing technologies include HMI-PLC/SCADA-controlled isolation-barrier aseptic filling, autoclave and VHP sterilization, CIP sanitization, SIP sterilization, and lyophilization. In the Filling Supervisor’s absence, the Lead performs and oversees manufacturing activities and provides signatory approval. The Lead directs, trains, and mentors junior Filling Operators; is responsible for proper operation of isolators, the lyophilizer, and other manufacturing equipment; and ensures proper use of batch documentation. The role also involves troubleshooting manufacturing processes and equipment, planning minor repairs, setting up parameters through HMI-PLC/SCADA systems, supporting technology transfer from R&D, and contributing to 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 at a satisfactory performance level, or 4 years of similar work experience in a related field, preferred.
One year of experience in a training role preferred.
Ability to perform basic mathematical calculations.
Mechanical aptitude, including the 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 Standard Operating Procedures, 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 requirements and respirator fit-testing requirements.

Nice To Haves

HMI-PLC/SCADA control data system experience is a plus.
Technical degree and/or some college in a relevant field.
At least 1 year of experience as a Filling Operator at a satisfactory performance level, or 4 years of similar work experience in a related field.
One year of experience in a training role.

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 according to production schedules.
Ensure only approved materials, equipment, documentation, and procedures are used.
Ensure personnel perform only tasks for which they have accurate and approved training records.
Staff filling-line stations for filling, stoppering, and capping operations, and offload finished product.
Ensure appropriate QC sampling techniques and procedures are followed and deliver samples to the QC laboratory promptly.
Perform equipment diagnostics and repairs as required.
Program equipment recipes for filling, lyophilization, and diagnostic procedures.
Attend training programs required by company SOPs, procedures, and policies.
In the absence of the Filling Supervisor, perform, oversee, and provide signatory approval for manufacturing activities.
Direct, train, and mentor junior Filling Operators as needed.
Ensure proper operation of isolators, the lyophilizer, and other manufacturing equipment, and proper use of batch documentation.
Troubleshoot manufacturing processes and equipment, and plan minor repairs during setup and operations.
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.