Process Technician

SUMMARY

- Executes SOPs for unit operations (daily and long term). Includes CIP, SIP, and cleaning and sanitization of the facility.
- Operates of buffer/media make-up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and UF/DF skids with varying mixes of automation and paper SOPs involved.
- Performs primary troubleshooting in time effective manner and act as a lead investigator SME of product/process deviations.
- Supports implementation of new technology for process execution and/or analysis. Interacts across the asset to achieve production schedule.
- Organizes daily routine when supervisors are not available.
- Reviews documentation daily as well as perform data entry
- Monitor, identify and communicate process and compliance trends Real Time.
- Archives various documentation according to established procedures.
- Required to modify and/or create job-related documentation including MBRs, SOPs, MFRs, work requests and others.
- Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
- Provides support during audits and with audit observation closure.
- Perform skills training and provide subject matter expertise to training materials.
- Maintains a safe working environment
- Thorough understanding of cGMP requirements and safety practices.
- Employs Automated systems, enterprise systems, and available technology to execute work.
- Engages in and supports a culture of innovation and sustainable improvement through ownership of improvement for work processes, equipment and environment.
- Strives for Right first time execution through flawless execution and ownership of the process.

SKILLS

- Manufacturing
- Purification experience