Validation Specialist

DiaSorin

  • Saluggia, Vercelli
  • Tempo indeterminato
  • Full time
  • 2 mesi fa
Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."Why Join Diasorin?Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!Job ScopeThe main responsibilities in charge to Validation Specialist are:Define industrialization processes, by ensuring that it is done according to the latest and most modern approaches, mainly for:
  • new products and/or processes;
  • design change of current products;
  • change of products/processes, raw materials already industrialized into Operations' area without impact on immunometric performance perceived by the user or declared;
  • technology transfer process from another Site to DSI or from DSI to another DiaSorin Production Site;
  • innovation and new continuous improvement ideas;
  • new equipment and/or automation processes, improvements/optimization of current ones, also including processes related to microbiological and environmental conditions, ensuring that it takes place according to the latest technological solutions and guaranteeing its full compatibility with products and/or processes currently in production, in close cooperation with Production Dept.
Maintain expertise and knowledge of state-of-the-art and updates of industrialization processes.Perform laboratory activities inherent to the areas of Manufacturing and/or QC Immuno Liaison (pilot lot/batch preparation, immunometric testing, and performance evaluation), in compliance with Quality Procedures and applying GMP, interacting with other laboratories/unitsKey Duties and ResponsibilitiesThe resource, included in the Assay Transfer Team, dedicated to the drafting and execution in the field of qualification protocols in accordance with predefined standards, ensuring compliance with the reference regulations, will carry out the following activities:
  • Drafting, verification and execution of qualification protocols and tests for general plants (Systems, Utilities) and process plants (equipment, new/change of process), carrying out DQ, IQ, OQ and PQ.
  • Drafting and reviewing Risk Assessment, VMP, VP, URS, GMP.
  • Definition of deliverables and project timelines ensuring full compliance with reference to Quality and timing.
  • Harmonization activities in order to guarantee the sharing and implementation of the same industrialization logics between the various DiaSorin production sites.
Education, Experience, and Qualifications
  • Higher diploma or university degree in technical-scientific field / Specialization on technical-scientific field.
  • Experience in Process Validation, Equipment Validation, Transfer of Technology, Process Harmonization, Industrialization or production in companies in the biomedical sector, preferably in the Medical Device sector, is appreciated.
  • Chemical, biology, biotechnology and immunometric assay knowledge.
  • Validation Process, Lean manufacturing principles and Industrial processes knowledge.
  • Microsoft Office package knowledge and Statistic principle.
  • Good written and verbal communication skills, interpersonal and organizational skills, time management skills.
  • Good English knowledge.
  • Excellent organizational and communication skills.
  • Strong analytical and problem-solving skills.
Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at or 1-800-328-1482 to request an accommodation.The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.

DiaSorin