Manufacturing Technician II (Aseptic)

Role Summary

Manufacturing Technician II (Aseptic) responsible for activities and procedures required for the manufacture and filling of aseptic products, following established procedures and receiving instructions on new assignments.

Responsibilities

• Operates production equipment according to SOPs, Batch Records, Manufacturing Directions, and Manufacturing Operating Procedures
• 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 OPMs
• Reviews logbooks 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 including read & understood, skills development and classroom training activities as 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 PPE such as safety glasses/goggles, gloves and safety shoes
• Ability to lift, pull or push equipment up to 25-50 lbs; stand for 6 hours in a production suite
• Ability to climb ladders and work platforms
• Ability to work around chemicals (alcohols, acids & bases)

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 is a plus