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Process Development Technician II
Ref No.: 17-15503
Location: Andover, Massachusetts
Job Description: • The Operations Technician 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. 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, centrifuges, 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.
• Manufacturing
• Quality Assurance
• Quality Control
• Quality Records Management
• Facilities Sanitization
• Engineering, Maintenance & Utilities
• Tech Transfer
• Environmental Health & Safety
• Supply Chain
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