Laboratory Technician (Devens)

SPECTRAFORCEDevens, MA, United States

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Job Title : Manufacturing Associate I - Cell Therapy

Job Duration : 6 Months with potential to extend

Job Location : Devens, MA

Shift Schedule : (There will be 6-8 weeks of training 7 AM 4 PM, Monday to Friday)

Rotational shift schedule

PURPOSE AND SCOPE OF POSITION

The client seeks Associates within manufacturing who bring enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. We are searching for enthusiastic and innovative individuals with a good understanding of good manufacturing practices to support routine manufacturing operations for Cell Therapy.

DUTIES AND RESPONSIBILITIES

Performing patient process unit operations and support operations described in standard operating procedures and batch records.
Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regimen as required to meet global Health Authority requirements.
Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
Completing training assignments to ensure the necessary technical skills and knowledge.
Assisting in setting up manufacturing areas and equipment / fixtures.
Perform facility and equipment commissioning activities.
Training others on SOPs, Work Instructions to successfully complete manufacturing operations.
Executing daily unit operations schedule that includes people, product, and material flow across multiple shifts.

REQUIRED COMPETENCIES

Education :

Bachelors in a relevant science or engineering discipline is preferred.

High school diploma and 2 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.

Preferred Qualifications :

Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.

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Laboratory Technician • Devens, MA, United States