Manufacturing Technician I (Aseptic)

Anika; Bedford (MA); On-site; USD 40,000 - 55,000; Full time

Job summary

A leading company in medical equipment manufacturing is seeking an Aseptic Manufacturing Technician to join their team in Bedford, MA. This entry-level position involves operating production equipment and ensuring compliance with cGMP standards. Applicants should be flexible, equipped with strong communication skills, and able to work in a biotech environment. Join us and play a crucial role in the manufacture of aseptic products.

Qualifications

• 0-1+ years of related manufacturing experience.
• Ability to work around chemicals.
• Good written and verbal communication skills.

Responsibilities

• Operate production equipment according to SOPs and Batch Records.
• Execute aseptic fill procedures including transfer, setup, and sanitization.
• Record data accurately in Batch Records and logbooks.

Skills

Communication Skills

Flexibility

Ability to Lift 25-50 lbs

Ability to Gown

Education

High school diploma or GED

Job description

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Position Scope:

The Aseptic Manufacturing Technician is primarily responsible for activities and procedures required for the manufacture and filling of Aseptic products. The position works under close supervision, following established procedures in daily activities.

Specific Tactical Responsibilities:

• Operate production equipment according to SOPs, Batch Records, Manufacturing Directions, and Operating Procedures.
• Execute procedures related to aseptic fills, including transfer, setup, sanitization, autoclaving, and process simulation.
• Follow work instructions for solvent recovery, clean out of place, and clean in place of complex equipment and components.
• Assist with troubleshooting and resolving process-related issues.
• Record data accurately in Batch Records, logbooks, and OPMs.
• Document all activities according to Good Documentation Practices.
• Report deviations and nonconformance to management.
• Maintain current training on all assigned procedures, including reading, understanding, skills development, and classroom training.

Job Complexity:

This role involves routine assignments requiring cGMP experience. The technician typically receives detailed instructions on routine tasks and training on new assignments.

Supervisory Responsibilities:

None

Required Qualifications:

• High school diploma, GED, or equivalent experience.
• 0-1+ years of related manufacturing experience.
• Flexibility to work varied hours.
• Good written and verbal communication skills.
• Ability to gown and enter biotech/pharmaceutical manufacturing areas, wearing PPE.
• Ability to lift 25-50 lbs and stand for 6 hours.
• Ability to climb ladders and work platforms.
• Ability to work around chemicals such as alcohols, acids, and bases.

Desired Skills and Experience:

• Experience in medical device manufacturing.
• Experience in clean rooms or aseptic techniques.
• Experience with automated equipment.
• Proficiency in computerized transactions and spreadsheets is a plus.

Additional Details:

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Management and Manufacturing
• Industry: Medical Equipment Manufacturing

This job posting is active. Apply now to join our team in Bedford, MA.