Technician, Manufacturing II (Wednesday to Saturday, 4:00pm - 2:30am)

Role Summary

Performs functions associated with 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 related to the production of parts, components and final materials. Uses systems such as LIMS, SAP, and automated control systems to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment. Determines and 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

• Associates degree in science (or equivalent experience), with 2+ years relevant experience. BS, with 1+ years relevant experience. BS in Engineering, with 0+ year relevant experience.
• Applies acquired job skills and company policies and procedures to complete assigned tasks.
• Works on assignments that are semi-routine in nature but recognizes the need for occasional deviation from accepted practice.
• Normally follows established procedures on routine work, requires instructions only on new assignments.

Skills

• Experience with cGMP manufacturing operations
• Data collection and analysis using LIMS, SAP, and automated control systems
• Setup, calibration, rework, and quality testing in manufacturing environments
• Cell culture (from vial thaw to production scale), column chromatography, and tangential flow filtration
• Equipment preparation (CIP/SIP) and process monitoring

Education

• Associate degree in science (or equivalent experience)
• BS in Engineering or related field