PACKAGING TECHNICIAN - Sterling Engineering : Job Details

Position Summary

The Manufacturing Associate I is a full-time non-exempt role located in Chicago, IL. This position involves the manufacturing of biotechnology products intended for clinical and commercial human use. Compliance with relevant policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and other government regulations is essential.

Essential Duties & Responsibilities

Conduct line inspections and line clearances in the packaging area.

Operate labeling, counting, blister packaging, checkweighing, serialization, aggregation, and tamper-evident sealing machines according to SOPs.

Perform visual inspections of labeled syringes, blister packs, printed cartons, or shippers for defects.

Responsible for the submission of samples.

Manually pack syringes with necessary components into cartons.

Verify the weight of cartons to ensure all components are present.

Pack approved cartons into shippers and perform palletization.

Submit documents and material requests to initiate packaging operations to the appropriate department.

Verify all drug product syringes before starting any packaging activities.

Electronically record all process steps as required.

Accurately complete logbooks, batch records, and other cGMP documentation in a timely manner.

Remove and dispose of soiled, expired, or rejected syringes and materials from the area.

Maintain packaging rooms and surrounding areas within the required conditions for cleanroom manufacturing.

Report any nonconformities or issues that arise during the shift to the supervisor.

Adhere to all safety, cGMP, and relevant policies, practices, and procedures.

Perform additional manufacturing and visual inspection tasks as required or assigned.

Requirements

Education:

High school diploma or GED preferred.

12 years of packaging experience in the pharmaceutical or biopharmaceutical industry.