Technician, Manufacturing I

Role Summary

Performs cGMP manufacturing operations within the biologics production facility, 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, SAP, and automated control systems to collect and evaluate operating data for on-line adjustments. Assists 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.

Skills

• cGMP manufacturing operations and biologics production.
• Experience using data collection and evaluation systems (LIMS, SAP, automated control systems).
• Ability to perform setup, calibration, rework, and quality testing of production materials.
• Cell culture (from vial thaw to production scale).
• Column chromatography and tangential flow filtration.

Education

• High School diploma (or equivalent)
• Associates degree in science
• Bachelor's degree (with 0+ year relevant experience)