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This **Senior Operator Manufacturing** role is responsible for executing manufacturing operations on site. Responsible for maintaining a clean and orderly work environment. Completes work in a timely manner and performs all tasks with emphasis on safety. Works collaboratively with Manufacturing, Engineering, Quality Assurance, and other functional experts to support all daily operational activities. Consults with management to resolve quality, production, and efficiency problems. Functions in conjunction with manager and functional experts on special department projects. Works with internal departments to ensure implementation, maintenance, and improvement of the quality management system. Performs the essential duties and responsibilities as listed in section below.

SHIFT SCHEDULE

Monday-Friday, 8hrs, 6:00AM-2:30PM. Potentially moving to a two-shift operation in 2026.

LOCATION NOTIFICATION:

Role is for a brand-new manufacturing facility that was opened in Braintree, MA to replace the Boston, MA facility. Initial training may be conducted out of the Boston, MA facility.

SUPERVISION RECEIVED

Reports to Manufacturing Supervisor

SUPERVISION EXERCISED

This position has no direct supervisory responsibilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

+ Manufacture biologically derived medical devices in a clean room environment (must be willing and able to follow clean room dress code requirements).

+ Accurately and completely fill out required documentation, following GDP GSOP requirements

+ Maintain compliance to cGMP/ISO systems

+ Follow batch processing per procedures and forms trained to

+ Operate processing inspection equipment

+ Maintain inventories of materials

+ Participate in process improvement and validation activities

+ Complete and pass all training and re-training requirements on-time

+ Perform general cleaning of the clean rooms and other manufacturing spaces

+ Perform general maintenance tasks as required

+ Must be comfortable in working with animal tissue (skin and/or biological fluid)

+ Perform all tasks with the emphasis on safety - Be respective of a ZERO tolerance policy

+ Perform all tasks safely and thoroughly in a timely manner

+ Follow SOP's, Work Instructions, and other company policies and instructions at all times

+ Use company provided PPE, manufacturing equipment, chemicals, and other equipment safely, responsibly, and compliantly

+ Maintain good attendance and scheduled work hours

+ Must be comfortable working with sharp rotary blades

+ Must be comfortable working in a cleanroom with required PPE

+ Must be able to work in teams and assist site with additional tasks as requested

+ Must be able to have good vision and ability to read measurement instrumentation for inspection

+ Must be able to safely lift and place items up to 50-60lbs.

+ Must be computer literate/Word/Excel, etc.

+ May be asked to complete Lead Operator tasks in absence of a Lead Operator

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

+ **Minimum required education and experience:** High School Diploma or equivalent with 4-6 years of experience

+ Excellent Attendance Record

+ Ability to read, write and understand English

+ Computer literacy is required

+ Ability to work overtime as required

+ Reliable Transportation

TOOLS AND EQUIPMENT USED

Lyophilizers (freeze dryers), pH meters, thermometers, balances (scales), sonicators, mixers, drop indicator, slicer machines, scalpels, temperature recorders, sealing machines