Aseptic Fill Operator I

American Regent, Inc.; Shirley (NY); On-site; USD 33,000 - 44,000; Full time

Benefits offered by this job

Healthcare

Life Insurance

Profit Sharing

Paid Time Off

401k Match

Job summary

American Regent, Inc. in Shirley, NY, is seeking an entry-level Manufacturing Team member to support aseptic filling and equipment prep in a cleanroom environment.

You will operate washer and capper machines, follow GMP/cGMP SOPs, and maintain accurate records while training to gown and work in gamma irradiated garments. This role offers exposure to critical manufacturing steps and a path to gowning qualifications.

Qualifications

• Minimum of high school diploma or GED preferred.
• Able to pass gowning qualification and Media Fill Qualification.
• Mechanical aptitude with the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment preferred.
• Ability to take feedback constructively and function in a team oriented work environment.
• Must be able to read documents in Standard English such as SOPs, maintenance schedules and operating manuals.
• Ability to work overtime as needed.
• Must become qualified to don Glass Washroom and APA gowning apparel.
• Must become qualified to perform Glass Washroom and APA cleaning.
• Must become qualified to operate washers and cappers.
• Must become qualified to operate aseptic fill room independently.

Responsibilities

• Performs duties required in the washer/capper area to established standards of productivity and quality as per SOPs.
• Adheres to GMP & cGMP.
• Perform duties according to SOPs.
• Operates washer and capper machines used in department.
• Accurately counts work done and keeps necessary records.
• Trays on containers and off loads work in process to support filling windows.
• Cleans work areas as needed and documents in appropriate log book.
• Notifies supervisor or lead person of any problems.
• Accurately completes all documentation associated with tasks performed.
• Stocks, gathers and stages manufacturing supplies and equipment.
• Gathers, stages and returns production materials as required to support manufacturing activities.
• Cleans and stores manufacturing equipment and areas as required to support manufacturing activities.
• Sanitization/disinfection of components, materials and production supplies to support the manufacturing process.

Skills

Mechanical aptitude

Team oriented

Able to read English documents

Education

High school diploma or GED

Tools

Washer and capper machines

Job description

American Regent, Inc. in Shirley, NY, is seeking an entry-level Manufacturing Team member to support aseptic filling and equipment prep in a cleanroom environment.

You will operate washer and capper machines, follow GMP/cGMP SOPs, and maintain accurate records while training to gown and work in gamma irradiated garments. This role offers exposure to critical manufacturing steps and a path to gowning qualifications.