Manufacturing Technician II (Aseptic)

Anika TherapeuticsBedford, MA
129d

About The Position

The Aseptic Manufacturing Technician II has primary responsibility for the activities and procedures required for the manufacture and filling of Aseptic products. The position follows established procedures in the execution of daily activities and receives instructions on new assignments.

Requirements

  • High school diploma, GED or equivalent experience
  • 2-4 years related experience in a cGMP manufacturing environment
  • Ability to work flexible hours to complete work activities
  • Must possess written and verbal communication skills
  • Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas; ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes
  • Ability to lift, pull or push equipment requiring up to 25-50 lbs; ability to stand for 6 hours in a production suite
  • Ability to climb ladders and work platforms
  • Ability to work around chemicals (alcohols, acids & bases)
  • Ability to work flexible hours to complete work activities

Nice To Haves

  • Manufacturing experience in a medical device industry
  • Experience working in a clean room or using aseptic technique
  • Experience using commercial scale automated equipment
  • Ability to perform computerized transactions and maintain spreadsheets are a plus

Responsibilities

  • Operates production equipment according to Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MD), and Manufacturing Operating Procedure (OPM)
  • Executes all procedures associated with aseptic fills (transfer, set-up, sanitization, autoclaving, process simulation, etc.)
  • Performs scheduled cleanings and sterilization of equipment
  • Supports change over activities
  • Troubleshoots and resolves process related issues
  • Records data into Batch Records, log books and OPM's
  • Reviews Logbook and Forms
  • Documents all work activities according to Good Documentation Practices
  • Reports procedural deviations and nonconformance to management
  • Maintains current training on all assigned procedures to include read & understood, skills development and classroom training activities as required

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What This Job Offers

Job Type

Full-time

Career Level

Entry Level

Industry

Chemical Manufacturing

Education Level

High school or GED

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