Summary

This entry level position is a member of the Manufacturing Team. The Manufacturing Team is 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 asepsis and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective, and professional behavior is displayed at all times. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting company goals. The Team Member will be able to participate in all aspects of the Manufacturing Process. The Manufacturing Process includes semi-automatic loading of glass vials, caps and seals into manufacturing machinery, semi-automatic unloading of finished product from the manufacturing machinery and the set-up/tear down and line clearances of the manufacturing equipment. The Team Member will assist with all activities associated with the manufacturing process under the direct supervision of Senior Manufacturing Team Members.

Job description

Nature and Scope

This entry level position is a member of the Manufacturing Team. The Manufacturing Team is 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 asepsis and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective, and professional behavior is displayed at all times. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting company goals. The Team Member will be able to participate in all aspects of the Manufacturing Process. The Manufacturing Process includes semi-automatic loading of glass vials, caps and seals into manufacturing machinery, semi-automatic unloading of finished product from the manufacturing machinery and the set-up/tear down and line clearances of the manufacturing equipment. The Team Member will assist with all activities associated with the manufacturing process under the direct supervision of Senior Manufacturing Team Members.

Essential Duties and 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.
Staff various stations in support of container washing, filling, stoppering, and capping. Will offload finished product.
Attends all training programs as required by Company SOPs, policies, and procedures.
Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

High School Diploma or GED required. Some college or technical training is a plus.
Minimum 2 years work experience in a related field 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 stand in one place for prolonged periods of time, monitoring equipment and processes.
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.

Physical Environment and Requirements

Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
Employee must be able to occasionally lift and/or move up to 50 pounds.
Physically able to work using restricted access barrier (RABS) or isolation containment devices.
Physically able to stand for long periods of time.
Must maintain cleanroom gowning and respirator fit testing requirement.

Requirements

High School Diploma or GED required
Minimum 2 years work experience in a related field 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 stand in one place for prolonged periods of time, monitoring equipment and processes
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
Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly
Employee must be able to occasionally lift and/or move up to 50 pounds
Physically able to work using restricted access barrier (RABS) or isolation containment devices
Physically able to stand for long periods of time
Must maintain cleanroom gowning and respirator fit testing requirement

Company overview

American Regent, Inc. is a leading U.S.-based pharmaceutical company and a member of the Daiichi Sankyo Group, specializing in the development, manufacturing, and supply of high-quality sterile injectables. Founded in 1967, the company has grown from small beginnings to become a major player in the pharmaceutical manufacturing sector, with a particular focus on IV iron therapy where it has been a market leader for over 25 years. The company operates manufacturing facilities in New York, Ohio, and Pennsylvania, serving healthcare providers, clinics, and hospitals across the United States and Canada. American Regent's portfolio includes both branded and generic injectable products, with notable offerings in animal health through its American Regent Animal Health division, which provides leading joint health treatments for horses and dogs. The company is committed to U.S.-based manufacturing and has made significant investments in modernizing and expanding its production capabilities to ensure reliable supply and responsiveness to market needs.