Aseptic Fill Finish Technician

US-NY-Melville
ID
2017-3458
# of Openings
1
Category
Manufacturing
Type
Direct Hire

Overview

Fill/Finish Technician is responsible for the compliant execution of the manufacturing process strictly adhering to cGMP; environmental health and safety guidelines; and any other related regulations which could apply. Under the general direction of the supervisor, this position shall be responsible for the hands-on execution of all activities in the production area. Activities include manual tasks and operation of automated equipment. In addition to making routine revisions to documents, technician may rewrite complex procedures or initiate new procedures as applicable

Responsibilities

Main Responsibilities

  • Perform hands-on execution of manual and automated Fill/Finish operations from equipment preparation, aseptic filling, thru product inspection and packaging. Equipment includes autoclave, syringe filling machine, COP cabinets, semi-automatic inspection machine, packaging equipment, and material handling devices.
  • Manual activities include equipment cleaning, room sanitization, equipment assembly and component replenishment, inspection and packaging.
  • Compliant and safe operation of processing equipment such as an autoclave, parts washer, aseptic filler, semi-automatic inspection machine, etc.
  • Ensure production area is in the highest state of readiness
  • Act as manufacturing troubleshooter to resolve and communicate issues related to equipment, process, and compliance to the supervisor
  • Support or conduct deviation investigation
  • Develop and implement CAPA
  • Participate in the creation and revision of Fill/Finish related documents.
  • Participate on continuous improvement teams and implement continuous improvement tools.
  • Follow basic safety/EHS requirements, SOPs, cGMP, work rules and other company's policies. Perform removal of hazardous waste.
  • Perform production area and associated equipment recovery activities such as cleaning of rooms, filler, parts washer, miscellaneous equipment, etc.
  • May perform other duties as assigned.

Qualifications

Background and Experience:

 

  • Associates required or 2 years of relevant experience; Bachelor’s Degree preferred
  • 2 Years’ Experience in pharmaceutical manufacturing is required and experience in aseptic or inspection/packaging is preferred.
  • Must be flexible, able to work extended hours (overtime), and alongside multiple departments

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