Lyophilization Technician (Tues. thru Sat.) 1:15pm -930pm
MORE INFORMATION ABOUT THIS JOB:
Operate and maintain the use of the lyophilizer and reconciliation of processed tissues/medical devices using aseptic technique. Maintain lyo production requirements to meet the needs of processing demands for all lyophilized tissue forms.
1. Maintain the operational / production requirements for the Lyophilizer ensuring the required daily throughput of tissue including remedial preventative maintenance and oil changes.
2. Knowledge of which Lyophilizers and programmed recipes are validated for all of the freeze-dried tissue forms.
3. Performs 100% inspection of all tissue grafts post-lyo for physical and aesthetic flaws per the Finished Goods inspection criteria.
4. Reconciles and seals finished goods into their respective final packaging post-lyophilization and maintains final packaging supply par levels using FIFO.
5. Responsible for accurate data entry of all tissue forms into the QAD system, including the manual, electronic and physical transfer of tissues from various locations.
6. Available to respond to Lyophilization concerns 7 days a week. Weekend responsibility for 36-hour lyo runs over the weekend of soft tissue and medical devices.
7. Attend meetings for development of future products and devices and completing associated validations for each.
8. Responsible for performing, distributing and documenting all pertinent testing which include personal, environmental, machine, residual moisture and supply integrity tests to the proper testing laboratory or representative.
9. Retain all documentation associated with the operation of the Lyo and the freeze-drying of tissue, including logs, cycle printouts, and batch records.
10. Identifies, responds and initiates non-conformances on an as needed basis pertinent to the Lyo operation.
11. Maintains and controls Lyo and tissue records per Operating Procedures.
12. Safety and hazardous waste/material handling.
13. Cap, seal and spark test all glass-bottled finished goods.
14. Assists on special projects and performs additional duties as assigned.
15. Responsible for the cleaning, sanitization, and maintenance of all Lyo equipment, machinery, supplies and work areas inside and outside the core and the proper documentation of these tasks.
16. Responsible for supporting MTF s safety programs and initiatives.
1. Minimum two years experience in one of the following areas:
* Tissue banking, surgical technician or nurse
* Production experience in a sterile environment in the pharmaceutical or medical fields
* Machine shop environment
* Tool and Die experience in a manufacturing environment
* Position requiring use of hand tools or procedures involving hand-eye coordination
2. High school diploma or equivalent required. College coursework in life sciences helpful.
3. Must be able to maintain a working knowledge of the Standard Operating Procedures.
4. Works in accordance with all FDA, ISO, AATB and GMP regulations.
5. Maintain sterile technique requirements associated with position.
6. Must be able to stand for long periods of time and work for up to four hours without a rest break.
7. Must be able to efficiently work in QAD and Master Control.
8. Able to lift up to 50 lbs.
9. Job requires a lot of repetitive motion, hand/eye coordination and dexterity and bending.
10. Must be available to work overtime when needed to meet production demands. This can include staying late, coming in early, holidays and weekends.
MTF is an Equal Opportunity and Affirmative Action Employer.