MTF Process Technician, 2nd Shift in Edison, New Jersey
The Process Technician is responsible for aseptically processing human cells, tissues and cellular and tissue based products for transplant in a controlled and regulated medical device environment. This position requires the technician to aseptically sterilize and maintain an ISO (International Organization for Standardization) certified cleanroom. This position also requires the technician to work with potential biologic hazardous tissue/waste. In addition, the technician will be responsible to work alone as well as in a team environment in the operations value chain in a 24/7 operation. This position may require mandatory overtime to meet business needs which include the scheduled workday as well as weekends.
Reads, comprehends, and adheres to all appropriate standard operating procedures.
Wears appropriate attire/PPE (personal protective equipment).
Prepares safe, quality tissue and maintains aseptic technique (practices and procedures under controlled conditions that minimize contamination by pathogens) at all times.
Verifies the use of sterile supplies and equipment before use and exposure to tissue.
Legibly and accurately completes written documentation of processing activities (from beginning to end of each process) on controlled forms.
Reads digital timers and or clocks and convert standard time to military time.
Reads measuring instrumentation: ruler, Micrometer, caliper, and graduated cylinders.
Uses caution while working with sharps and cutting equipment and follows any necessary procedures while processing tissue.
Accurately adds, subtracts, measures and calculates ratios for liquids and powders.
Measures, labels, and packages all tissue accurately and according to standard operating procedure.
May prepare necessary tissue and environmental samples for testing according to standard operating procedures.
Follows the work order and/or designated Planning unit goals to ensure maximization of human tissue for transplant.
Performs quality inspection review of all processed tissue and paperwork.
Performs line clearance accounting of materials provided to execute the process.
Ensures waste is placed in the appropriate biological hazardous waste containers/bags and label and document according to procedure.
Processes one donor at a time in a process location and complete the appropriate cleaning process and documentation and/or data entry for the environment upon completion.
May work on more than one process at a time in separate locations while maintaining proper aseptic technique.
May retrieve tissue from the designated location and completes the necessary log documentation for proper traceability of tissue.(exempt)(non-exempt)
May transfer tissue to freezer for storage and completes necessary documentation.
May prepare chemicals in appropriate ratios for processing activities and cleaning solutions.
May clean and sanitize cleanroom and equipment using chemicals including; peracetic acid and ethanol to ensure an aseptically controlled sterile environment.
Ensures supplies are used in a FIFO (first in – first out) and ensures supplies are appropriately stocked.
May perform quality and safety observations as assigned.
May work closely with support departments when necessary; Process Engineering, Planning, Quality Engineering, Quality Assurance, Quality Control, Facilities, Supply Chain, Chemical Operations, R&D, Donor-Log-In, P&L, and Marketing.
Attends internal and external training as assigned.
Assists with special projects and perform additional duties as assigned. (exempt)(non-exempt)
Senior Process Technician
Performs all duties as listed above.
Assists Supervisor(s) and Team Leaders(s) on cross training initiatives.
Will be training Process Technicians on a given process.
Assists with training, training documentation and competency of other technicians and new hires.
Assists with area and processing observations for competency verification.
Advanced Process Technician
Performs all duties listed above.
Works with Engineering & R&D on new processes.
May act as back-up to Team Leader in their absence.
Performs project related work.
Assists training function with appropriate training and competency regarding new processes.
Education: High School Diploma/GED
Years of Experience: 1 - 2 years
Other: Experience in one of the following: tissue banking, surgical technician, nursing or related medical technology background, medical device or pharmaceutical manufacturing, ISO class 8 or less cleanroom / controlled environment.
Specialized Knowledge, Technical Skills, and Abilities:
Read and understand military time. Good documentation skills.
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Job Location US-NJ-Edison
Shift 2nd Shift
Job ID 2021-5693