Manufacturing Technician
Job Description
Manufacturing Technician
Boston, MA
Position Overview:
This is a Manufacturing Technician position in the Injectables Manufacturing group which is part of the R&D Biologics Development organization. This group is responsible for producing Phase 1 and 2 clinical drug products. The major accountability for this position is to run the fill and finish line, producing the final drug product. All activities are closely supervised and work is reviewed upon completion. The work schedule is Monday through Friday, first, shift with occasional weekend work required.
Key Responsibilities:
>Prepare and run filling line for vial and syringe filling operations.
>Perform daily process activities in compliance with standard operating procedures (SOPs). Prepare all process-specific equipment for use in assigned areas.
>Operate equipment in compliance with SOPs.
>Assure compliance with cGMP requirements (current good manufacturing practices). Complete and review associated production records.
>Cross train on final product inspection.
Basic Qualifications:
>High school diploma/GED or Biotech certificate with a minimum of 3 years experience in a cGMP manufacturing environment or Bachelor's degree and a minimum of 1 year of experience in a cGMP manufacturing environment
>Experience with aseptic processing.
>Knowledge and demonstrated understanding of GMP and how it applies to specific responsibilities and manufacturing operations.
>Excellent communication and collaboration skills.
>Self-motivated, detailed oriented, have the ability to manage own time, be flexible, team-oriented, and demonstrate good troubleshooting skills.
>Experience in writing SOPs.
Preferred Qualifications
>Bachelor's degree in Biology, Chemistry, Biochemistry, or Chemical Engineering.
>Strong verbal and written communications, effective time management, and organizational skills are essential to success in this role.
>Visual inspection experience.
>Special Working Conditions
>Visual acuity of 20/30 near vision with or without correction required
>Ability to lift up to 50 pounds.
>Push/pull up to 50 pounds to move loaded, wheeled carts with assistance from another worker Frequent sitting, walking, standing, bending, and squatting.
>May require standing and walking up to 70% of the day.
>Frequent reaching between waist and shoulder level.
>Occasional reaching up and out.
>Repetitive grasping and movement of hands and fingers.
>May involve work with hazardous materials.
Recommended Skills
- Asepsis
- Attention To Detail
- Biochemistry
- Biology
- Biotechnology
- Certified Global Meeting Planner