Manufacturing Technician II (Aseptic)

Position Scope:

The Aseptic Manufacturing Technician II has primary responsible 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.

Specific Tactical 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
  
  

Job Complexity:

The position works on assignments that are routine in nature where cGMP experience is required to perform work activities. The Aseptic Manufacturing Technician II normally follows procedures on routine work, requires instruction and training on new assignments.

Supervisory Responsibilities:

None

Required Qualifications:

• 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
  
  

Desired Experience, Knowledge, and Skills:

• 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