Technician, Manufacturing I

Role Summary

Performs cGMP manufacturing operations within the biologics production facility, including working with engineers on setup and calibration tasks, as well as performing rework and quality testing of parts, components and final materials. Uses systems such as LIMS and SAP to collect and evaluate operating data to support on-line adjustments to products, instruments, or equipment. May assist in developing methods and procedures to control or modify the manufacturing process.

Responsibilities

• Shipping finished materials.
• Maintaining inventory levels.
• Sampling of in process and raw materials.
• Running glass washer / autoclave.
• Buffer / media preparation.
• Equipment preparation (CIP / SIP).
• Cell culture (from vial thaw to production scale).
• Column chromatography.
• Tangential flow filtration.

Qualifications

• High School diploma (or equivalent experience), with 2+ years experience. Associates degree in science, with 1+ years relevant experience. Bachelor's Degree with 0+ year relevant experience.
• Acquires job skills and learns company policies and procedures to complete routine tasks.
• Works on assignments that are routine in nature, requiring limited judgment.
• Has the ability to recognize when accepted practices are deviated from.
• Normally receives detailed instructions on all work.
• Works under close supervision.