LifeLink Tissue Bank has an immediate opening for a Validation Project Specialist. This position is required to manage on-going activities related to process validation of new and existing projects to include, but not limited to, protocol development and execution, equipment, process and packaging validation.
In conjunction with the Validation Manager, Processing and the Research and Development Department, facilitate all activities required to fully validate processes and equipment, including but not limited to BF testing, log reduction studies, sterilization of tissue based products/re-useable equipment and final product packaging. Is expected to work independently with minimum supervision, able to lead complex projects following regulatory requirements and industry best practices.
Develop, write and execute protocols for the process validation of new processes
Generation of validation master plan (project based)
Actively participate in cross/departmental meetings/projects.
Coordinate, track and manage validation projects
Analyze data from validation activities
Assist Validation Manager in the tracking of project costs and annual budgeting process
Coordinate relationships with outside vendors and contractors
Assist management in developing/maintaining partner relationships.
Track the status of all outstanding reports and consult with Validation Manager as needed to ensure on time delivery of reports and data.
Coordinate with other departments to ensure equipment, materials and supplies are available in order to facilitate validation activities
Assist in the development of training programs related to new processes/equipment for all operations staff.
Assist with coordinating dose audits/bioburden testing for gamma irradiated tissue based products, which includes review of dose audit and bioburden results.
Collect and review data and compile reports.
Present to management and senior leadership as needed
Performs/provides research for development of technical and quality assurance protocols.
Assists Management in areas of tissue banking research.
Compensation is commensurate with experience. LifeLink has a very comprehensive benefit package offered to full-time employees. Key features of the package are LifeLink’s generous company paid pension plan, and insurance coverage which includes medical, dental, disability, and life; all non-contributory on the part of the employee.
LifeLink Foundation is a non-profit community service organization dedicated to the recovery and transplantation of an increasing number of high quality organs and tissues for transplant therapy. The Foundation attempts to work sensitively, diligently, and compassionately with donor families to facilitate the donation of desperately needed organs and tissues for waiting patients.
LifeLink Foundation is a non-profit community service organization dedicated to the recovery of life-saving and life-enhancing organs and tissue for transplantation therapy. The Foundation works in a sensitive, diligent, and compassionate manner to facilitate the donation of desperately needed organs and tissues for waiting patients, support research efforts to enhance the available supply of organs and tissue for transplant patients.