Senior Aseptic Manufacturing Technician

Job Title: Sr. Manufacturing Tech

Work Location: Middlesex County, Massachusetts

Summary:

The Aseptic Manufacturing Technician has primary responsibility for the activities and procedures required for the manufacture and filling of Aseptic products. The position works under close supervision and follows established procedures in the execution of daily activities.

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 OPM’s
• 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 I normally receives detailed instruction on routine work and training on new assignments.

Supervisory Responsibilities:

None

Qualifications:

• High school diploma, GED or equivalent experience
• 0 – 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)
• 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