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_Kedrion is looking for a_ **_Validation Specialist – Computer Systems_** _to join our team and play a critical role in ensuring the compliance and reliability of computerized systems across our GxP operations, including manufacturing and laboratory environments. As a Subject Matter Expert (SME), you will lead validation efforts and support the development, commercialization, and lifecycle management of our product portfolio._

_This is an exciting opportunity to make a real impact by shaping our validation program in alignment with FDA, EU, and GAMP 5 standards._

_Job Role and Responsibilities_

+ _Lead validation projects for GxP systems—authoring and executing protocols and documentation (IQ/OQ/PQ, validation plans, traceability matrices, etc.)_

+ _Ensure systems comply with all regulatory standards and industry best practices for data integrity and electronic records._

+ _Conduct risk assessments, system impact evaluations, and periodic reviews._

+ _Evaluate systems for key compliance areas like audit trails, access controls, data migration, and backup._

+ _Own and maintain system validation procedures and documentation across the site._

+ _Partner with cross-functional teams to support change control, CAPAs, and system upgrades._

+ _Mentor junior team members and contribute to training initiatives._

+ _Serve as CSV lead during internal and external audits and regulatory inspections._

_Qualifications_

+ **_Education_** _: Bachelor’s degree in computer science, engineering, life sciences, or a related field._

+ **_Experience_** _: At least 2 years of hands-on experience validating computerized systems in a regulated environment._

+ **_Knowledge_** _:_

+ _Solid understanding of validation principles (GAMP 5) and regulatory frameworks (21 CFR Part 11, EU Annex 11)._

+ _Familiarity with quality system processes (change control, deviations, CAPAs)._

+ _Strong grasp of data integrity, audit trails, user access management, and periodic review processes._

+ **_Skills_** _:_

+ _Strong analytical thinking and problem-solving skills._

+ _Clear communication and documentation abilities._

+ _Ability to work independently and collaboratively in cross-functional teams._

+ _Comfortable managing multiple priorities in a fast-paced environment._

+ _Experience mentoring or coaching others is a plus._

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.

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.