Aseptic Technician II (1pm-9:30pm)

American Regent, Inc.; Shirley (NY); On-site; USD 40,708 - 46,838; Full time

Job summary

American Regent, Inc. is seeking an Aseptic Technician II to support sterile filling operations in our Shirley, NY facility. The role focuses on setup, breakdown, and preventive maintenance of aseptic equipment, with emphasis on safety and accurate documentation.

Candidates should have a high school diploma or GED and relevant experience in cGMP environments; willingness to work flexible shifts and overtime is required.

Qualifications

• Ability to perform essential duties in a cGMP manufacturing environment.
• Reading and understanding Standard Operating Procedures (SOPs) in English.
• Basic knowledge of safety programs and PPE requirements.
• Familiarity with sterile processing and aseptic workflows is preferred.

Responsibilities

• Set up and break down sterile liquid filling machines in an aseptic environment.
• Troubleshoot equipment and system issues as they arise.
• Perform preventive maintenance and update records as required by SOPs.
• Identify and correct unsafe conditions and ensure PPE compliance.
• Maintain clean and organized work area and assist during shutdowns.

Skills

Aseptic machinery

Preventive maintenance

Troubleshooting

Safety awareness

Reading SOPs

Education

High School Diploma or GED

Tools

Small hand tools

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

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 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.

Expected Hourly Rate

$29.55-$34.00

The hourly rate displayed is the minimum and maximum hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

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.