Aseptic Manufacturing Technician, 1st Shift: 6:00am-2:30pm

Anika Therapeutics•Bedford, MA

16h•$23 - $30•Onsite

About The Position

The Aseptic Manufacturing Technician II has primary responsibility for the activities and procedures required for the manufacture and filling of aseptic products. This role follows established procedures in the execution of daily activities and receives instruction on new assignments.

Requirements

High school diploma or GED, or equivalent experience.
2+ years of related experience in a cGMP manufacturing environment.
Ability to work flexible hours to complete work activities.
Strong written and verbal communication skills.
Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas and 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. and stand for up to 6 hours in a production suite.
Ability to climb ladders and work platforms.
Ability to work around chemicals including alcohols, acids, and bases.

Nice To Haves

Manufacturing experience in the 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.

Responsibilities

Operates production equipment according to Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MD), and Manufacturing Operating Procedures (OPM).
Executes all procedures associated with aseptic fills (transfer, set-up, sanitization, autoclaving, process simulation, etc.).
Performs scheduled cleaning and sterilization of equipment.
Supports changeover activities.
Troubleshoots and resolves process-related issues.
Records data into Batch Records, log books, and OPMs.
Reviews log books 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-and-understood, skills development, and classroom training activities as required.