Manufacturing Technician I (Aseptic)
Anika
Full-time
Remote friendly (Bedford, MA)
United States
$45,000 - $55,000 USD yearly
Operations
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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 – 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