Filling Operator II (1st)

American Regent, Inc.•New Albany, OH

About The Position

The Filling Operator II is a 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 where required, keeps manufacturing area and equipment records neat and accurate, and follows safe, effective, and professional practices. In coordination with Production Management, the team supports other departments and production schedules and contributes to company goals. The operator participates in all aspects of the manufacturing process, including semi-automatic loading of glass vials, stoppers, caps, and seals into manufacturing machinery; unloading finished product; and setting up, tearing down, and clearing manufacturing equipment. The operator is expected to become proficient in manufacturing activities and work with minimal supervision, while receiving direction, training, and mentorship from Senior Filling Operators. With assistance from a senior team member, the operator troubleshoots minor equipment adjustments and repairs, and selects parameters requiring senior approval for some manufacturing technologies using HMI-PLC/SCADA control and data systems.

Requirements

High school diploma or GED.
Ability to perform basic mathematical calculations.
Mechanical aptitude, including the ability to assemble, troubleshoot, and perform minor repairs on manufacturing equipment.
Ability to stand in one place for prolonged periods while monitoring equipment and processes.
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 and 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 work using restricted access barrier (RABS) or isolation containment devices.
Ability to stand for long periods.
Must meet cleanroom gowning and respirator fit-testing requirements.

Nice To Haves

Technical degree and/or some college in a relevant field.
At least one year as a Filling Operator I with satisfactory performance, or two years of similar work experience in a related field.

Responsibilities

Gather, stage, and return production materials in support of manufacturing activities.
Assist team members with equipment assembly, cleaning, and storage as required.
Maintain the cleanliness of manufacturing equipment and areas.
Staff stations supporting container washing, filling, stoppering, and capping, and offload finished product.
Ensure that only approved documentation and procedures are used.
Oversee the gathering, staging, and sampling of production supplies, materials, and equipment required to support manufacturing.
Oversee and perform QC sampling activities required to support manufacturing.
Perform minor machine diagnostics and repairs as required.
Attend training programs required by company SOPs, procedures, and policies.
Perform other tasks and duties assigned by management.