Job Details

  • Title: Process Development Technician
  • Code: RCI-PFE-16641-1
  • Location: Andover Massachusetts (MA) 01810
  • Posted Date: 09/11/2019
  • Duration: 12 Months
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  Job Description

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.

Role Responsibilities:

  • 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

Required Skills

  • Mammalian Cell Culture                
  • Purification
  • SOPs, cGMP

Qualifications:

  • 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.