Clinical Operations

  • location: Andover, MA
  • type: Contract
  • salary: $21.56 - $25.36 per hour

job description

Chat with me now! - https://flashrecruit.com/jobs/300055

Process Development Technician II

Job Summary

  • 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.

Job 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, 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.

Education & Qualifications

  • High School diploma and 4 years of relevant experience required.
  • 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.

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Chat with me now! - https://flashrecruit.com/jobs/300055

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