- Title: Process Development Technician
- Code: RCI-PFE-16641-1
- Location: Andover Massachusetts (MA) 01810
- Posted Date: 09/11/2019
- Duration: 12 Months
- Name:Vishal Trivedi
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 435
The Process 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 (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, 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.
- Support Media Formulation.
- Media Formulation experience needed.
- Manufacturing, SOP, SIP, GMP experience
- Mammalian Cell Culture
- SOPs, cGMP
- High School diploma and 4 years of relevant experience required. BA 2+ years
- 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.