Verification And Validation Biologist (Ref_0923_Bio_Vv)

Verification and Validation Biologist (REF_0923_BIO_VV)JOB DESCRIPTIONThe resource will be involved, as part of the Verification and Validation (V&V) team in the development of In Vitro Diagnostics (IVD) and For Research Use Only (RUO) products.DUTIES AND RESPONSIBILITIES• Prepares biological samples from different origins (e.g. blood, forensic and FFPE)• Develops and performs cell-based assays for verification and validation activities• Collaborates with other departments, including engineering, technical support and manufacturing• Develops conference materials, application notes and scientific papers• Critical review of product specifications to assess requirements testability• Define test strategies for the Validation of applications, workflows and high technology products for IVD market• Test Plan, Test execution and Test Reports editing needed for delivery of the IVD products• Documentation according to ISO 13485 and FDA QSR 820 requirements• Design Change management: requirements impact analysis and regression test definitionBASIC REQUIREMENTS• PhD in sciences or equivalent acquired by professional experience• Master's Degree in Biology or Biotechnology• At least 5 years of experience in science field with proven experiences in cell culture, cell-based assay development, image-based technologies, flow cytometry and sorting• Good skills in planning and execution of research projects• Fluent English (written and spoken)• Ability to interact and communicate with people from all areas and level of business, both verbally and written form• Ability to create and give presentations and updates to team members on an international project• Teamwork and problem solvingPREFERRED QUALIFICATIONS• Experience in V&V area and/or in IVD/Medical Devices development is a plus• ISO13485 & FDA 21CFR820 Medical Device• Availability to national and international business tripsMenarini Silicon Biosystems S.p.A. is committed to equal opportunity in the terms and conditions of employment for job applicants without regard to race, colour, religion, sex, sexual orientation, age, gender identity or gender expression, national origin. #J-18808-Ljbffr