Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine. **JOB SUMMARY** The Associate Validation Specialist at Kedrion provides technical input to Kedrion’s plasma fractionation & parenteral products process design, commercialization, and aseptic manufacturing science advancement. This role is crucial for Kedrion’s success, and it will be a key contributor to Kedrion’s drug product and process development, commercialization, and life cycle management of the product portfolio. As a key contributor to Kedrion’s commercialization development and aseptic process introduction into clinical and commercial facilities, the Associate Validation Specialist must integrate and successfully utilize knowledge and information generated by cross functional teams involved in product, process, delivery systems, packaging, and equipment (engineering, analytical, quality, regulatory, clinical and commercial manufacturing) to positively influence Kedrion practices and ensure success through the commercialization lifecycle. **ESSENTIAL JOB FUNCTIONS** Supports Sr. Validation Specialist on process improvement projects. Works together with the other Validation Specialists to support and perform Qualification and Validation activities related to process, cleaning, and equipment. Partners with Engineering, Maintenance, Manufacturing, and other Quality areas to assure all standards, regulations and guidelines are followed in the manufacture of company products. Interacts with all areas and levels of the company in addition to regulatory agencies, vendors, consultants, and other intended parties. The Associate Validation Specialist has the objective of maintaining high quality standards for the qualification and validation in compliance with all applicable regulatory requirements. **MAIN DUTIES AND RESPONSIBILITIES** Core + Performs generation and cleaning validation protocols and execute which include training operation personnel, witnessing cleaning cycles, collecting rinse and swab samples, and submitting samples to QC labs for testing. + Support cleaning verification sampling for routine cleaning monitoring and to support ongoing investigation. + Assists in drafting and executing validation/qualification documents (IQ, OQ, PQ) related to equipment, utilities and software associated with the development of drug products. + Conduct Periodic Reviews and remediation of gaps discovered during Periodic Reviews. + Support requalification of equipments such as Autoclave, SIP of tanks, Freezers, Cold Rooms (Temperature Controlled Units), Stability Chambers etc. + Support shipping validation of Fractionation intermediates and final sterile drug product. + Support execution of process validation activities. + Performs generation of summary reports for validation/qualification protocols which include data gathering, compiling, analyzing, and summarizing etc. + Helps to drive best practices and technical advancements across Kedrion network and will be utilized for their knowledge and expertise of areas as they develop. + Participates in global cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships. **REQUIREMENTS** Education, Qualifications & Experience + Associate’s degree in biomedical engineering, Bioprocessing, Chemical Engineering or Biological Sciences preferred or 1 to 3 years of documented experience in a validation role preferred. + Fractionation process and Aseptic fill and finish experience preferred. + Multi-parametric downstream purification processes and TFF/DF preferred. + A strong knowledge of biological processes, equipment, utilities, and knowledge of software validation/qualification principles and lifecycle documentation a plus. + Must possess a strong understanding of all Science/Engineering principles applicable to Biopharmaceutical and Pharmaceutical Development/Manufacturing. + Experience in Biopharmaceutical Manufacturing or Process/Technology Development in a technical role preferred. + Good written and oral communication skills are a must. + Basic knowledge around project planning and prioritization preferred. + Logical and independent thinking. + Enthusiastic personality and positive attitude. + Prior experience in FMEA is a plus. + Sound understanding and demonstrated application of statistical methods/tools a plus. + In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements a plus + Multi-tasking abilities + Outstanding organizational skills + Ability to operate in a fast-paced, multi-disciplinary industrial environment Kedrion Biopharma offer a number of benefits to qualifying employees, including: - Medical, vision and dental insurance - Life and AD&D insurance - Paid holidays - PTO accrual - Sick time - 401(k) with Company match - and much more! Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have! All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status. Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security. Please note that salary ranges are calculated based off levels of relevant experience, education and certifications.