Filling Operator I (3pm-11:30pm)

American Regent, Inc.•Shirley, NY

2d•Onsite

About The Position

This entry-level position is a member of the Manufacturing Team, responsible for manufacturing safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The role ensures aseptic and sanitary conditions are maintained, that manufacturing area and equipment records are accurate, and that safe and professional behavior is displayed. The Team Member will participate in all aspects of the Filling Process, including dispensing components, cleaning, assembling, and sanitizing equipment, and aseptic filling. This includes loading vials, stoppers, caps, and seals into machinery, operating filling and capping machines, unloading finished product, and performing line clearances. The Filling Operator I assists with all activities associated with the filling process under direct supervision.

Requirements

Minimum of high school diploma or GED preferred.
Able to pass gowning qualification and Media Fill Qualification.
Mechanical aptitude with the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment preferred.
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.
Must become qualified to don Glass Washroom and APA gowning apparel.
Must become qualified to perform Glass Washroom and APA cleaning.
Must become qualified to operate washers and cappers.
Must become qualified to operate aseptic fill room independently.

Nice To Haves

Mechanical aptitude with the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment.

Responsibilities

Performs duties required in the washer/capper area to established standards of productivity and quality as per standard operating procedures.
Adheres to good manufacturing practices (GMP & cGMP).
Perform duties according to the company’s standard operating procedures (SOPs).
Operates washer and capper machines used in department.
Accurately counts work done and keeps necessary records.
Trays on containers and off loads work in process (WIP) to support filling windows.
Cleans work areas as needed and documents in appropriate log book.
Notifies supervisor or lead person of any problems.
Accurately completes all documentation associated with tasks performed.
Stocks, gathers and stages manufacturing supplies and equipment.
Gathers, stages and returns production materials as required to support manufacturing activities.
Cleans and stores manufacturing equipment and areas as required to support manufacturing activities.
Sanitization/disinfection of components, materials and production supplies to support the manufacturing process.
Required to become gown qualified, maintain training status and wear gamma irradiated garments consisting of a coverall, hood, mask, gloves, boots and goggles.
Required to become qualified cleaner for the aseptic processing area.
Attends all training programs as required by Company SOPs, procedures and policies.
Perform any other tasks/duties as assigned by management.
Keeps work area clean and orderly.