Process Technician - 1st Shift

JOB DUTIES:

- Set-up and execution of cGMP unit operations with a focus on Cell Culture (Flasks, biowaves and bioreactors up to 6000L), harvest (centrifugation, depth filtration, microfiltration), media preparation, and glasswash. Includes cleaning and sanitization of the facility and equipment (CIP, SIP, COP, autoclaving, depyrogenation, etc).
- Accurately follow oral, written, and electronic instructions in the production area and document daily operations in GMP batch records and logs.
- Operate manual and automated equipment. Individuals will be expected to learn and work with enterprise system such as LabWare LIMS and SAP.
- Support implementation of new technology for process execution and/or analysis.
- May be responsible for authoring and revising cGMP documents including batch records and SOPs.
- Responsible for data entry and Real Time process monitoring.
- Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
- Executes routine manufacturing activities including Purification, Cell Culture, solution formulation, and equipment preparation (set-up, CIP, SIP).
- First-line technical support within their assigned Asset Group, collaborating with outside groups as needed.
- Serve as the operations point of contact for campaign start-up with roles in technology transfer, site assessment, generation of cGMP documentation, suite preparation, process execution, and summary reporting.
- Coordinate suite clearance and product changeover.
- Process monitoring including Real Time review of process parameters and process data/trend analysis.
- Communicate process performance across shifts and departments.
- Implement process enhancements, measures and responds to equipment capability and implements new technologies.
- Support procurement and validation of new equipment and technologies.
- Support or champion compliance investigations, commitments (CAPA), and change controls.
- Provide support during audits and with audit observation closure. Perform skills training and provide subject matter expertise to training materials.
- Position is first shift.

SKILLS:

Manufacturing experience.