Description:

TGen's CLIA (BSL-2) lab located in Flagstaff, Arizona is looking for a Validation Specialist to join the team.

The Validation Specialist is responsible for developing, validating, and implementing new processes into the production lab. The validation specialist will be required to work with a variety of groups to plan and present on future validation work. Additionally, the validation specialist will lead laboratory investigations, ensuring that proper reagents/instruments are ready for validation and that appropriate documents (e.g., SOPs, Biological Agent Reference Sheets, etc.) are in place for the validation process. The Validation specialist will document validation processes and validation results in written reports. Finally, the validation specialist will be responsible for implementing validated procedures into the production laboratory, ensuring that appropriate SOPs are in place and that all performing employees are trained on the process deviations.

Essential functions:

Plan validation and verification efforts to ensure regulatory, quality, and safety priorities are adequately addressed.

Conduct validation and verification experiments ensuring that regulatory, quality, and safety priorities are adequately addressed.

Interpret and present on previous validation or verification activities to a diverse group of stakeholders.

Implement changes in the production laboratory through the creation and maintenance of SOPs, hands on training opportunities, and open communication with production staff and management.

Author summary reports for executed validation protocols.

Serve as technical expert, mentor, and peer reviewer for system, data and application integration test methods.

Mentor team members on how to best meet compliance objectives and strategy, and implement into operational practices.

Liaise with other groups to identify SOPs that need to be created, revised, removed, or replaced.

Requirements:

Requirements:

The Validation Specialist will have an in-depth knowledge of all processes occurring in the production laboratory with a detailed knowledge of the molecular/chemical interactions that are occurring during these processes. The idea candidate will have experience with experimental design and clear scientific communication skills

The Validation Specialist must have a bachelor's degree in Biology, Chemistry, Molecular Biology or other related field and at least one year of experience in a production laboratory or in another high throughput laboratory that focuses on techniques that are similar to those being implemented at TGen North.

Per CLIA regulations, applicant must provide transcripts that verify

24 semester hours of science courses that include -
(i) Six semester hours of chemistry;
(ii) Six semester hours of biology; and
(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination

General Information:

The Pathogen and Microbiome Division of TGen (TGen North) is focused on translating microbial genomics science into positive impacts on human health. The Division is home to the Southwest One Health Collaborative (www.southwestonehealth.org), combining genomics and other next generation sciences with the need for interdisciplinary health research involving human, animal and environmental health sectors. TGen's One Health Collaborative is a newly formed research endeavor based upon our existing expertise and infrastructure for dangerous pathogens, genomics, animal models, disease ecology, public health, microbial forensics, molecular epidemiology, select agents, bioinformatics, computational capacity, metagenomics, microbiome analysis, environmental microbiology, clinical research partners and team approach to science. TGen North works closely with the three Arizona state universities, including a successful 15-year collaboration with the Pathogen and Microbime Institute at Norther Arizona University, under the leadership of world-renowned microbial genomics professor Dr. Paul Keim. TGen North has a strong population health program, supporting local, tribal, state federal and international health agencies, and has been at the forefront of the COVID-19 response since Jan 2020. TGen continually seeks to add new talent from differing disciplines and experiences who are dedicated to achieving its mission of positively impacting human health. The TGen North facility is located in Flagstaff, Arizona and has BSL2 and BSL3 micro labs, cell culture, state-of-the-art molecular labs, a robust high-throughput sequencing center, and uses the best-in-class HPC environment at Headquarters in Phoenix, AZ. All TGen North teams are supported by an experienced bioinformatics and software development team and a dedicated full-service administrative team.

Additionally, in 2016, TGen joined forces with The City of Hope in California, allowing for direct connectivity to a large clinical research and delivery center. The City of Hope affiliation is already providing a wealth of opportunities to advance Microbiome as a critical piece of clinical care and management of chronic and complex diseases.

Flagstaff is a university town with a resident population of about 67,000, and is rich in cultural diversity. Located at the base of the majestic San Francisco Peaks, Flagstaff is 140 miles north of Phoenix at the intersection of Interstate 17 and Interstate 40. With its elevation of 7,000 feet and four-season climate, Flagstaff is ideal for year-round outdoor activities. Nearby environmental attractions include the Grand Canyon, Oak Creek Canyon, Sedona, Monument Valley, Sunset Crater, Meteor Crater, and Arizona Snowbowl. Flagstaff also has rich a rich history in scientific discovery and application from Lowell Observatory (where Pluto was discovered), the rich environmental resource setting, and a growing biotechnology sector that includes TGen and Gore and Associates (a global leader in medical device

PI185810115