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

Anika; Bedford (MA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Discretionary bonus program

Comprehensive healthcare benefits

Health savings account

401(k) plan with up to 5% companymatch

Job summary

Anika is seeking a Sr. Aseptic Technician to support manufacture and filling of aseptic products. The role requires following established procedures, exercising judgment, and ensuring compliance throughout the manufacturing process.

Responsibilities include operating production equipment, performing aseptic fill procedures, cleaning and sterilizing equipment, and assisting with changeovers while maintaining proper batch records and documentation.

Qualifications

• Minimum high school diploma or GED or equivalent experience.
• Strong written and verbal communication skills.
• Ability to use computer applications and MS Office.

Responsibilities

• Operates production equipment per SOPs, Batch Records, and MD/OPM.
• Executes all aseptic fill procedures including transfer, setup, sanitization, autoclaving, and process simulation.
• Performs scheduled cleaning, sterilization, and supports changeover activities.

Skills

Communication

Computer skills

Safety awareness

Education

High school diploma or GED

Tools

Microsoft Office

ERP SAP

Job description

The Sr. Aseptic Technician performs 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 with ERP systems, preferably SAP.

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.

• 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

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.