Manufacturing Technician II; Crosslink 2nd Shift

Role Summary

The Crosslink Technician II is responsible for the activities and procedures required for cross linked hyaluronic acid product production. The position follows established procedures in the execution of daily activities and receives instructions on new assignments.

• Operates production equipment according to SOPs, Batch Records, Manufacturing Directions, and Manufacturing Operating Procedure
• Executes all procedures associated with cross linked hyaluronic acid product production
• Adheres strictly to written work instructions to perform solvent recovery, clean out of place, and clean in place of complex equipment and components
• 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 OPMs
• 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

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

• 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

• Physical demands: ability to lift, push or pull equipment and stand for extended periods as required by production activities