Filling Operator (10 pm-6:30 am)

Nature and Scope

This is an entry level position designed to provide on the job training and experience to individuals who want to get into the pharmaceutical industry. During training, individuals will learn the basics of working in a sterile environment to manufacturing lifesaving pharmaceuticals as a member of the Manufacturing Team. Upon successful completion of the training period demonstrating proficiency in assigned tasks the individual will be promoted to Filling Technician I.

The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company standard operating procedures, policies, and current good manufacturing practices. They ensure aseptic 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 always displayed. 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 assist in all activities associated with the filling process under the direct supervision of Senior Manufacturing Team Members.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Set up and operation of vial washing and capping machinery, including removal, proper installation, and verification of change parts.
• Utilize testing equipment to verify quality of filled vials including seal force tester and headspace analyzer.
• Operate equipment to enter batch information, change run parameters and settings.
• Pull samples as required.
• Segregate completed vials as required.
• Conduct visual inspection of completed vials.

• Receive and return material and components from and to the warehouse. Count, measure, or dispense required amounts and stage for use.
• Clean and prepare materials and components for use in production. Issue, scrap, and return materials and components using an MRP system.
• Sterilize equipment, materials, components, and supplies using an autoclave, fogging machine, and disinfectant solution.
• Disassembly, assembly, and cleaning of equipment and supplies used in the production of injectable pharmaceuticals.
• Set up and operation of equipment to perform CIP cycles on equipment.
• Prepare solutions for cleaning rooms and equipment, passivation of equipment and neutralization of wastewater.
• Aseptically clean and sterilize rooms including ceilings walls, floors, and stationary equipment.
• Visually inspect filled vials, pulling filled vial samples, and transferring filled product.
• Creation of vial standards.
• Pre and postproduction line clearance of production rooms.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• High school diploma or GED required. An associate degree in chemistry or other science field is a plus.
• Ability to perform basic mathematical calculations.
• Possesses mechanical aptitude with the ability to assemble, troubleshoot, and perform minor repairs on manufacturing equipment.
• Ability to meet and maintain Class 100 Certification for sterile compounding/transfer (Hilliard facility) as well as maintain cleanroom gowning and respirator fit testing requirements.
• Ability to stand in one place for prolonged periods of time, monitoring equipment and processes.
• Must be able to work using restricted access barrier (RABS) or isolation containment devices.
• 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.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.