Aseptic Preparation Operator

Position Summary:

Responsible for preparing batch specific materials inside and outside of the cleanroom. Transports materials, supplies, and finished products to designated locations. Works with planning/scheduling and incoming warehouse to assist in reviewing inventory levels and identify/resolve material availability issues.  Operates parts washers, sterilizers, autoclaves.  Collaborates with production to ensure workflow does not stop due to material availability and proactively helps drive overall operational efficiency. 

Essential Functions:

• Prepares batch specific materials (staging) inside and outside of the cleanroom.


• Maintains full gown and garb qualification


• Retrieves, prepares, stages, and delivers materials and supplies to production, packaging & inspection (finishing), and distribution center.


• Operates parts washers, sterilizers, autoclaves, and other relevant equipment


• Communicates frequently and works inclusively with Team Leads, Supervisors, Scheduling, MQA, Training and other site personnel to meet the goals of the production department.


• Complies with all federal, state, regulatory bodies (FDA, DEA, BOP, DEC, OSHA) and local municipalities.


• Meets site goals and objectives as part of a team


• Initiates and fosters a spirit of cooperation within and between departments


• May perform high-level cleaning/disinfecting of sterile cleanrooms


• May put items into stock (physical), perform cycle counts, supports physical inventory counts at required frequency as needed.


• May transport recycling and packaging waste to final on-site disposal location


• Observes all environmental, health, and safety policies


• Performs other duties and tasks as assigned by management


• Maintains proper documentation in appropriate logbooks and batch records.


• Qualified in or must become qualified in 1-5 processes outlined in the Operations Growth Chart.

Education and Experience:

- High school diploma or equivalent required.

- Prefer two years experience in a related field (manufacturing or pharmacy)

Knowledge, Skills and Abilities:

- Good interpersonal skills and willingness to work with others

- Good oral and written communication skills

- Good organizational skills and attention to detail

- Ability to prioritize tasks

- Ability to work effectively both as part of a team and individually

- Ability to give/receive constructive criticism