Manufacturing Associate II , Cell Therapy Devens MA
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Job Location:
Devens, MA - USA
Monthly Salary:
$ 29 - 35
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
The Manufacturing Associate II Cell Therapy within Manufacturing brings enthusiasm intellectual curiosity scientific rigor and a desire to help drive novel programs. The incumbent must be goal-oriented flexible and able to work efficiently with safety and quality in mind with a good understanding of good manufacturing practices to support routine manufacturing operations for Cell Therapy.
Shifts Available:
6am 6pm rotating schedule including holidays and weekends
6pm - 6am - rotating schedule including holidays and weekends
Responsibilities:
Performing patient process unit operations and support operations described in standard operating procedures and batch records.
Demonstrates strong practical and theoretical knowledge in their work
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.
Collaborates with support groups on recommendations and solving technical and operational problems.
Identifies innovative solutions
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.
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 regiment as required to meet global Health Authority requirements.
Knowledge and Skills:
Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations
Must have the ability to work assigned shift (Day Night Weekends and/or Holidays).
Must be able to work in a cleanroom environment and perform aseptic processing
Must be comfortable being exposed to human blood components.
Must be able to be in close proximity to strong magnets.
Preferred Qualifications:
Aseptic processing in ISO 5 biosafety cabinets universal precautions for handling human derived materials in BSL-2 containment areas.
Basic Requirements:
High school diploma and 2 years of experience in cGMP bioprocessing manufacturing cell therapy manufacturing or relevant experience
Bachelors in relevant science or engineering discipline and relevant experience is preferred
Experience in cell therapy manufacturing including Cell washing processes and automated equipment is preferred.
Experience with Cell separation techniques and automated equipment and Cryopreservation processes and equipment a plus.
Working Conditions:
A. PHYSICAL /MENTAL DEMANDS:
Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time throughout the day.
Carrying weight Pushing Pulling Lifting - Required to carry lift push and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.
Climb - Required to climb (use of stepladders in production areas or stairwells) several times a day.
Bend and Kneel - Required to bend or kneel several times a day.
Overhead work - Required to perform overhead reaching during handling of production materials / files / supplies up to 25 pounds several times a day throughout the day.
Moving Head and Neck Required movement of head/neck while using computer
applications and handling of production equipment and materials several times a day throughout the day.
Twisting - Required movement of twisting waist while setting up equipment several times a day throughout the day.
Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day throughout the day.
Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include but not limited to: safety shoes safety glasses aprons face shields lab coats full body gowns hairnets gloves and hearing protection.
Compensation Overview:
Devens - MA - US: $29.09 - $35.25per hour
Required Experience:
IC
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
