Aseptic Technician II (4am-12:30pm)
American Regent, Inc.
Summary
The Aseptic Technician II role entails the execution of setup, breakdown, repair, and preventive maintenance of equipment/systems used for conveying sterile containers and liquid filling of vials/ampules.
Job description
Nature and Scope
The Aseptic Technician II role entails the execution of setup, breakdown, repair, and preventive maintenance of equipment/systems used for conveying sterile containers and liquid filling of vials/ampules.
Essential Duties and Responsibilities
- Set up and break down of sterile liquid filling machines in an Aseptic Environment.
- Troubleshoot equipment/system issues.
- Perform preventive maintenance.
- Identification and correction of unsafe conditions.
- Maintain Safety Expectations including use of proper Personal Protective Equipment (PPE).
- Ensure proper change parts in associated fill rooms needed for setups.
- Maintain housekeeping of own work area.
- Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
- High School Diploma or (GED Equivalent), required.
- 2 years of relevant experience in a cGMP manufacturing working environment or mechanical experience, preferred.
- 2 year of sterile processing experience, preferred.
- Ability to understand safety programs (e.g. Lock out / Tag out, line breaking).
- Basic Use of small hand tools.
- Basic Knowledge of pneumatics, solid state relays, and transformers, preferred.
- Basic knowledgeable in cGMP (Current Good Manufacturing Practices), preferred.
- Ability to follow instructions and document activities as outlined in SOPs.
- Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
- Basic Microsoft Office and Windows skills.
- Flexibility to work multiple shifts and off hours during shutdown plus overtime.
Physical Environment and Requirements
- Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
- 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.
- Must be able to occasionally lift up to 50 lbs. and stand for prolonged periods of time while fulfilling job duties.
Requirements
- High School Diploma or (GED Equivalent), required.
- 2 years of relevant experience in a cGMP manufacturing working environment or mechanical experience, preferred.
- 2 year of sterile processing experience, preferred.
- Ability to understand safety programs (e.g. Lock out / Tag out, line breaking).
- Basic Use of small hand tools.
- Basic Knowledge of pneumatics, solid state relays, and transformers, preferred.
- Basic knowledgeable in cGMP (Current Good Manufacturing Practices), preferred.
- Ability to follow instructions and document activities as outlined in SOPs.
- Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
- Basic Microsoft Office and Windows skills.
- Flexibility to work multiple shifts and off hours during shutdown plus overtime.
- Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
- Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
- Must be able to occasionally lift up to 50 lbs. and stand for prolonged periods of time while fulfilling job duties.
Benefits
- Healthcare
- Life insurance
- Profit sharing
- Paid time off
- Matching 401k
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.