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

Anika Therapeutics, Inc.; Bedford (MA); On-site; USD 55,000 - 90,000; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Health Savings Account

Company 401(k) match

Stock purchase plan

Paid time off

Stock awards

Total rewards

Job summary

Anika Therapeutics, Inc. seeks an Aseptic Manufacturing Technician II to support the manufacture and filling of aseptic products. You will follow SOPs, batch records and MD/OPM, performing fills and routine equipment sterilization, with emphasis on cGMP adherence.

Ideal candidates have a high school diploma or GED and at least 2 years of related cGMP manufacturing experience, with strong communication skills and the ability to work 2nd shift in Bedford, MA.

Qualifications

• 2+ years of related experience in a cGMP manufacturing environment.
• Strong written and verbal communication skills.
• Ability to gown and work in biotechnology/pharmaceutical environments with PPE.

Responsibilities

• Operate production equipment per SOPs, Batch Records, MDs and OPMs.
• Execute aseptic fills including transfer, set-up, sanitization, autoclaving, and process simulation.
• Perform scheduled cleaning and sterilization of equipment.
• Support changeover activities and troubleshoot process issues.
• Record data into Batch Records and log books; review forms and logs.
• Maintain training on procedures and document deviations per standards.

Skills

cGMP experience

Communication skills

PPE compliance

Physical stamina

Education

High school diploma

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.

2nd Shift 1:00pm-9:30pm