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SUMMARY DESCRIPTION

This 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 after September 2025.

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.

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 Senior Operator tasks in absence of a Senior 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 2-4 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

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position.  In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak and have the ability to move throughout all locations of the building. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Ability to travel via car, train and/or airplane to domestic and international locations as needed.

ADVERSE WORKING CONDITIONS
The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position.

Adverse exposure may result from the handling of hazardous and bio-hazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes. 

SELECTION GUIDELINES 
Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.

DISCLAIMER 
The duties listed above are intended only as illustrations of the various types of work that may be performed.  The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. 
The job description does not constitute and employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.