MANUFACTURING TECHNICIAN
Company: Artech LLC
Location: Warren
Posted on: March 19, 2023
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Job Description:
Job Title: MANUFACTURING TECHNICIAN
Location: Warren, NJ
Duration: 12+ months
Job Description: -
This is 100% ONSITE
Performance of the daily manufacturing support services for Warren
CAR T clinical manufacturing operations, as per Standard Operating
Procedures (SOPs) in a controlled, cleanroom environment.
This position is primarily a first shift role however, start and
end times are subject to change based on business demands.
This position is a member of the Manufacturing Operations
organization and reports to the Manager of CAR T Clinical
Manufacturing.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Basic mathematical skills
- Proficient in MS Office applications
- Flexibility to accommodate schedule demands as needed
- Understanding of cleanroom behavior
- Knowledge of cGMP/FDA regulated industry requirements
- Understanding of Good Documentation Practices
Education and Experience: High School diploma/GED
DUTIES AND RESPONSIBILITIES:
- Kit receipt, verification and sanitization.
- Stocking kits in manufacturing suites as needed prior to the
start of manufacturing.
- Cycle counting, requesting and restocking consumable
supplies.
- Requisition and delivery of additional materials required during
manufacturing.
- Pre/post use disinfection of process stations and Biological
Safety Cabinets.
- Daily end of day disinfection of processing labs and equipment
after process completion.
- Weekly extended disinfection of processing labs and
equipment.
- Runner for samples and raw materials when needed.
- Delivery of samples to QC.
- Manufacturing suite inventory management.
- Other duties assigned, as necessary.
WORKING CONDITIONS (US Only):
- Intermittent walking and sitting to perform job functions;
however, ability to sit or stand for extended periods of time may
be necessary.
- Physical dexterity sufficient to use computers and complete
documentation.
- Sufficient vision and hearing capability to work in job
environment.
- Ability to lift up to 25 pounds.
- Must have the ability to work around laboratories and controlled,
enclosed, restricted areas.
- Cleanroom garments and personal protective equipment will be
required in designated areas which cover head, parts of the face,
core body, and legs/feet.
- Makeup, gum, nail polish, or other potential microbial sources
are prohibited in restricted areas.
- Flexibility to don clean room garments and personal protective
equipment (PPE).
- Clean room environment is an enclosed, restricted space, with
assigned pressure and temperature conditions.
- Use of reagents, chemicals, and exposure to sanitization agents
are expected.
- Ability to work in the vicinity of strong magnets.
- Potential routine exposure to human blood components is
possible.
- Designated areas prohibit food, any outside materials such as
cell phones, tablets, at a minimum.
This job description is intended to describe the general nature and
level of work being performed by the person assigned to this
position. The primary duties and responsibilities are intended to
describe those functions that are essential to the performance of
this job.
This job description does not state or imply that the above are the
only duties and responsibilities assigned to this position. There
are other duties and responsibilities that are considered
incidental or secondary to the overall purpose of this job.
Employees holding this position will be required to perform any
other job-related duties as requested by management.
Additional Job Requirements:
None
Keywords: Artech LLC, Elizabeth , MANUFACTURING TECHNICIAN, Professions , Warren, New Jersey
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