|Reference # : ||18-01375
||Title : ||Process Development Technician II|
|Position Type : ||Contract|
|Experience Level : ||
||Start Date / End Date : ||04/30/2018 / 04/29/2019
| Description |
|The Process Technician II owns and drives the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule. The Operations Technician will work on interdisciplinary self-directed teams, to define and implement process improvements, participate in process troubleshooting.|
• Executes SOPs for unit operations (daily and long term). Includes CIP, SIP, and cleaning and sanitization of the facility
• Operates 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.
• Supports implementation of new technology for process execution and/or analysis.
• Interacts across the asset to achieve production schedule.
• Reviews documentation daily as well as perform data entry – Monitor, identify and communicate process and compliance trends real time.
• Archives 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.
• Responsible for keeping training current.
• 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.