Aseptic Manufacturing Technician 2nd Shift 1:00pm-9:30pm

Anika; Bedford (MA); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Discretionary bonus

Healthcare benefits

401(k) with company match

Employee stock purchase plan

Job summary

Anika in Bedford, MA is seeking an Aseptic Manufacturing Technician II to operate production equipment and perform aseptic fills in a controlled environment. You will log data, follow strict procedures, and maintain training to ensure compliance with cGMP standards.

The role requires 2+ years in a cGMP setting and a high school diploma or GED, with flexibility for varying hours. A background in medical device/biotech manufacturing is a plus.

Qualifications

• High school diploma or GED or equivalent.
• 2+ years of related experience in a cGMP manufacturing environment.
• Flexibility to work varying hours.
• Strong written and verbal communication skills.
• Gowning and PPE requirements for manufacturing areas.
• Lift up to 25–50 lbs and stand for extended periods.
• Ability to climb ladders and work on platforms.
• Comfort handling chemicals used in production.

Responsibilities

• Operates production equipment according to SOPs, Batch Records, MD and OPM.
• Executes aseptic fills (transfer, setup, sanitization, autoclaving, process simulation).
• Performs scheduled cleaning and sterilization of equipment.
• Supports changeover activities and resolves process issues.
• Records data in Batch Records and log books and reviews forms.
• Maintains training and reports deviations per procedures.

Skills

cGMP experience

Communication skills

Lifting 25-50 lbs

Education

High school diploma or GED

Job description

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.
• 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.