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

Anika Therapeutics, Inc.; Bedford (MA); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Discretionary bonus

Healthcare benefits

HSA

401(k) with company match

Employee stock purchase plan

Paid time off

Job summary

Anika Therapeutics, Inc. is seeking a Sr. Aseptic Technician to perform routine and non-routine activities in the manufacturing and filling of aseptic products.

The role follows established procedures and uses judgment to resolve basic issues, with opportunities to contribute to process improvements. Qualified candidates will have a high school diploma or GED and 4–6 years of cGMP manufacturing experience; ability to lift up to 50 lbs, wear PPE, and work flexible shifts in a clean room

Qualifications

• 4–6 years of related experience in a cGMP manufacturing environment.
• Ability to lift up to 25–50 lbs. and stand for up to 6 hours in a production suite.
• Ability to gown and gain entry to manufacturing areas with PPE.
• Proficiency with Microsoft Office applications.
• Strong written and verbal communication skills.
• Ability to work flexible hours.
• Experience in clean room or aseptic technique is a plus.

Responsibilities

• Operate production equipment per SOPs, Batch Records, MDs and OPMs.
• Execute aseptic fill procedures (transfer, setup, sanitization, autoclaving, process simulation).
• Perform scheduled cleaning and sterilization of equipment.
• Support changeover activities and troubleshoot process issues.
• Review manufacturing documentation for compliance and coordinate sample prep/testing.
• Document all activities per Good Documentation Practices and report deviations.
• Assist quality system activities and maintain training on procedures.

Skills

Strong communication

Computer skills

Flexible hours

PPE compliance

Manual dexterity

Education

High school diploma or GED

Tools

SAP

Job description

What You’ll Do

TheSr. Aseptic Technicianperforms routine and non-routine activities and procedures required for the manufacture and filling of aseptic products. This role follows established procedures in the execution of daily activities and uses judgment in resolving basic issues or making recommendations.

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.
• Initiates work orders.
• Reviews manufacturing documentation for compliance.
• Coordinates sample preparation and testing.
• Records data into Batch Records, log books, and OPMs.
• Documents all work activities according to Good Documentation Practices and recommends document revisions.
• Reports procedural deviations and nonconformance to management.
• Assists Lead Technician in quality system generation, reviewing log books and non-critical forms, and maintaining floor metrics.
• 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 moderately difficult, requiring judgment in resolving issues or making recommendations. The Sr. Aseptic Technician normally receives little instruction on daily work and general instructions on newly introduced assignments.

What You Bring

• High school diploma or GED, or equivalent experience.
• 4–6 years of related experience in a cGMP manufacturing environment.
• Ability to work flexible hours to complete work activities.
• Strong written and verbal communication skills.
• Proficiency in computer skills and Microsoft Office applications.
• 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.
• Experience with ERP systems, preferably SAP.

Salary & 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