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Pharmaceutical Manufacturing Specialist
4 weeks ago
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. As a Filling Operator, you will learn the basics of working in a sterile environment to manufacture lifesaving pharmaceuticals as a member of the Manufacturing Team.
Key Responsibilities
• Set up and operate vial washing and capping machinery, including removal, proper installation, and verification of change parts.
• Utilize testing equipment to verify the quality of filled vials, including seal force testers and headspace analyzers.
• Operate equipment to enter batch information, change run parameters, and settings.
• Pull samples as required and segregate completed vials as needed.
• Conduct visual inspections of completed vials and receive and return material and components from and to the warehouse.
• 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.
• Disassemble, assemble, and clean equipment and supplies used in the production of injectable pharmaceuticals.
• Set up and operate equipment to perform CIP cycles on equipment and prepare solutions for cleaning rooms and equipment.
• Aseptically clean and sterilize rooms, including ceilings, walls, floors, and stationary equipment.
• Visually inspect filled vials, pull filled vial samples, and transfer filled product.
• Create vial standards and perform pre- and post-production line clearance of production rooms.
Requirements
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 and possess 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, and 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, and 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.
• 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 is 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.
