Collabera Process Technician in Andover, Massachusetts
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. High School diploma and 2 years of relevant experience required.
• 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.
• Interacts across the asset to achieve production schedule.
• 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.
• Experience in a GMP manufacturing environment is desired.
• Familiarity and experience with either purification processes or mammalian cell culture.
• Support operations (such as solution preparation and/or operation of autoclave/depyrogenation ovens) is not essential, but is highly desirable.
• The ability to execute against SOP’s and document entries in a cGMP compliant manner.
• Ability to interpret and prioritize workflow to maintain the production schedule.
• Effective verbal and written communication skills.
GMP ,SIP, CIP, buffer preparation, media preparation, UF/DF, chromatography