Technician, AV Access will be responsible for handling technical aspects of the Human Vascular Graft Manufacturing Process and Cell Expansion Process including bioreactor set up and maintenance, media feeds, cell inoculation, cell passage, media preparation, tubing manifold assembly, tissue storage, packaging, labeling, and quality control in accordance with current Good Tissue Practices (cGTP), current Good Manufacturing Practices (cGMP), Standard Operating Procedures, Work Instructions, and Product Specifications, in a cleanroom environment.
Essential Duties and Responsibilities:
- Adhere to standardized, hands on technical training in accordance with current and revised SOPs, established work instructions and product specifications.
- Complex vessel bioreactor setup and technical maintenance, media feeds, media preparation, decellularization of vessels using automated Decelluralization machine, packaging, labeling and sterilization of final product using the Steris VHP machine.
- Continuous monitoring of many vessels to ensure proper and consistent growth with QC testing to ensure final graft functionality.
- Strong aseptic technique in a Biological Safety Cabinet.
- Proficiently perform thaws, media feeds, cell counting, cell passage, and media preparation.
- Accurately record processing data and information in accordance with cGMP and cGTP guidelines.
- Accountable for conducting oneself in a manner that represents the company’s guiding principles.
- Accurately document material transactions and physically transfer product to designated storage locations.
- Clean, organize, and maintain processing work areas as required by SOPs and work instructions.
- Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.
- Based on tenure in the department, train and develop manufacturing skills of junior technicians with guidance from the AV Access Trainer.
- Perform on a regular basis, with strong scientific understanding, the following scientific techniques, not limited to: osmolality testing, blood gas analysis, and bioreactor pressure testing.
- Overtime and Holiday availability, as required.
- Input on quality and operational disruptions.
- Assist on projects of moderate scope including operational excellence, safety, authoring procedures under guidance.
- 4 year college degree in Life Science field or in place of college degree, 3 years of laboratory cellular or biotechnology experience with high school diploma or equivalent is required.
- 2 + years’ experience in lab or aseptic environment
- Demonstrated knowledge of aseptic technique and good documentation practices
- Proficiency in Microsoft applications, specifically Excel, Word and Outlook
- 3 years’ experience in a lab or aseptic environment and Good Manufacturing Practices
For consideration you must apply online, submit a current resume and meet the minimum requirements. All offers are contingent upon a background check, drug screen and other contingencies may apply depending upon the position. Candidates within a 50 mile radius of the hiring zip code may receive first consideration. If you require special accommodations, please contact us at 720-873-0213.
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