Manufacturing Technician I (Aseptic)

Role Summary

Manufacturing Technician I (Aseptic) - The Aseptic Manufacturing Technician performs activities and procedures required for the manufacture and filling of Aseptic products under close supervision, following established procedures in daily tasks.

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.).
• Adheres to written work instructions to perform solvent recovery, clean out of place, clean in place of complex equipment and components.
• Assists with troubleshooting and resolution of process related issues.
• Records data into Batch Records, log books and OPMs.
• 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.

Qualifications

• High school diploma, GED or equivalent experience
• 0 ‚Äì 1+ years related experience in a manufacturing environment
• Ability to work flexible hours to complete work activities
• Must possess good 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

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

Education

• Not specified

Additional Requirements

• None