*Overview/Risks
• 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 Process Technician to aseptically sterilize and maintain an ISO (International Organization for Standardization) certified cleanroom. Process Technicians are required to work with potential biologic hazardous tissue/waste. In addition, the Process Technician will be responsible to work independently 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 and holidays.
• Sunday Night -Friday Morning 11pm-7am
• Responsibilities
• + Reads, comprehends, and adheres to all appropriate standard operating procedures.
• Competent in the standard competencies in accordance with the new hire check list.
• Possess an understanding of the donor verification and check in and check out processes. (Edison only.)
• Gain Technical and MTF tissue product knowledge through participation in classroom, hands-on experience and LMS. Must maintain greater than a 90% completion rate for LMS training.
• Prepares safe, quality tissue and maintains aseptic technique (practices and procedures under controlled conditions that always minimize contamination by pathogens).
• Must be proficient and certified on 10% of the processes. (Edison Only) For Pennsylvania technicians see the Tech Level Guidance document.
• Assists the processing team in all activities related to the semiannual and quarterly shutdowns such as CORE break down, CORE loading and CORE unloading.
• Wears appropriate attire/PPE (personal protective equipment).
• 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.
• Measures, labels, and packages all tissue accurately and according to standard operating procedure.
• Prepare necessary tissue and environmental samples for testing according to standard operating procedures as requested.
• Follows the work order and/or designated Planning unit goals to ensure maximization of human tissue for transplant.
• Performs line clearance accounting of materials provided to execute the process. Performs quality inspection review of all processed tissue and paperwork.
• Ensures waste is placed in the appropriate biological hazardous waste containers/bags and label and document according to procedure.
• May retrieve tissue from the designated location and completes the necessary log documentation for proper traceability of tissue.
• 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.
• Transfer tissue to freezer for storage and completes necessary documentation as needed.
• May prepare chemicals in appropriate ratios for processing activities and cleaning solutions.
• 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.
• Perform quality and safety observations as assigned
• Enroll and complete the following Learning & Development classes in the Service Excellence Certification Program: Business Etiquette, and Effective Listening Skills.
• 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.
• Responsible for their own professional development and be accountable for own results. Attends internal and external training as assigned.
• Assists with special projects and perform additional duties as assigned.
• Qualifications
• + High School Diploma/G.E.D.
• Accurately adds, subtracts, measures, and calculates ratios for liquids and powders.
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• Job Location
• _US-NJ-Edison_
• Type
• _Full-Time_
• Category
• _Operations_
• Shift
• _3rd Shift_
• Job ID
• _2024-7096_
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