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

Anika Therapeutics, Inc.; Bedford (MA); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

Discretionary bonus program

Comprehensive healthcare benefits

Health savings account (HSA)

401(k) with up to 5% company match

Employee stock purchase plan

Paid time off

Long-term incentives including stock

Total Rewards program

Job summary

Anika Therapeutics, Inc. in Bedford, MA is seeking an Aseptic Manufacturing Technician II to perform aseptic manufacturing and filling of products. The role follows established procedures and requires training on new tasks.

Strong cGMP experience and ability to work in cleanroom environments are essential. You will operate production equipment, perform aseptic fills, and maintain documentation, with a focus on quality and compliance.

Qualifications

• Minimum education: high school diploma or GED or equivalent.
• At least 2+ years in a cGMP manufacturing environment.
• Ability to work flexible hours to complete shifts.
• Strong written and verbal communication skills.
• Ability to gown and enter cleanroom areas with PPE.

Responsibilities

• Operate production equipment according to SOPs, Batch Records, MDs, and OPMs.
• Execute all aseptic fill procedures (transfer, setup, sanitization, autoclaving, process simulation).
• Perform scheduled cleaning and sterilization of equipment.
• Support changeover activities.
• Troubleshoot and resolve process-related issues.
• Record data into Batch Records and log books; review forms.
• Document all work per Good Documentation Practices.
• Report deviations and nonconformances to management.
• Maintain current training on procedures and required read-and-understood, skills development, and classroom training.

Skills

Aseptic technique

cGMP experience

Equipment operation

Documentation practices

Verbal & written communication

Education

High school diploma or GED

Job description

What You’ll Do

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.

How You’ll Contribute

• 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.

What It Takes

The position works on assignments that are routine in nature where cGMP experience is required to perform work activities. The Aseptic Manufacturing Technician II normally follows procedures on routine work and requires instruction and training on new assignments.

What You Bring

• 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.
• Ability to work flexible hours to complete work activities.

Nice to Have

• 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.

Compensation and Benefits

The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location.

Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.

The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

1st Shift: 6:00am - 2:30pm