Senior Manufacturing Technician, 1st Shift; Aseptic

Role Summary

The Sr. Aseptic Technician performs routine and non-routine activities and procedures required for the manufacture and filling of Aseptic products. The position follows established procedures in the execution of daily activities and uses judgement in resolving basic issues or making recommendations.

• 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
• Initiates work orders
• Reviews manufacturing documentation for compliance
• Coordinates sample preparation and testing
• Records data into Batch Records, log books and OPMs
• Documents all work activities according to Good Documentation Practices; recommend document revisions
• Reports procedural deviations and nonconformance to management
• Assists Lead Technician in Quality System Generation, Reviewing Log Books and Non-Critical Forms and maintaining floor metrics
• 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:
  
  4-6 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:
  
  Must be proficient in computer skills and Microsoft Office
• Required:
  
  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
• Required:
  
  Ability to lift, pull or push equipment requiring 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)
• Preferred:
  Manufacturing experience in a medical device industry
• Preferred:
  Experience working in a clean room or using aseptic technique
• Preferred:
  Experience using commercial scale automated equipment
• Preferred:
  Experience with ERP preferably SAP