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Lab Technician/ Operations Technician – Manufacturing
Ref No.: 18-16637
Location: Andover, Massachusetts
Job Title: Lab Technician/ Operations Technician – Manufacturing
Location: One Burtt Road, Andover, MA 01810
Duration: 12 Months

Shift: Other (02:00 PM - 02:00 AM)

Additional Skills:
  • High School diploma required.
  • Experience in a GMP manufacturing environment is desired.
  • Familiarity and experience with 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.
  • 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 (daily and long term). Includes CIP, SIP, and cleaning and sanitization of the facility
  • Operates media make up tanks, glass washers, autoclaves, 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.
  • Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
  • 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.

If Yes, how many hours of overtime (on average) per week?: 8 hours every other week

What will the resource be working with, or, have exposure to?:
Biohazardous Agent work (such as menigiditis, staph aureus, Lenti Virus, streph pneumoniae)