Process & Cleaning Validation Specialit I

13 ago - Italia
Experteer Italy

Process & Cleaning Validation Specialit I In this role you plan, execute, and document validation across equipment, processes, and computer systems to ensure product quality and regulatory compliance. You will collaborate with cross-functional teams to uphold high standards and support continuous improvement. The position offers growth within Thermo Fisher Scientific, a global leader in serving science. You will tackle validation challenges with a focus on regulatory alignment, data integrity, and quality assurance. This is a meaningful opportunity to contribute to critical healthcare and environmental safety initiatives. * Plan, execute, and document IQ/OQ/PQ validation activities for equipment, processes,



and computer systems * Support regulatory compliance with FDA/EMA requirements and data integrity standards * Collaborate with cross-functional teams to maintain quality and drive continuous improvement * Perform risk assessments and ensure proper validation documentation and traceability * Manage multiple validation activities and prioritise accordingly * Travel between sites may be required * Bachelor's degree in a related field * Strong knowledge of validation principles (IQ/OQ/PQ) * Experience with equipment qualification and process validation * Familiarity with FDA/EMA regulatory requirements * Proficient in statistical analysis (Minitab) * Strong documentation and communication skills * Experience with risk assessment methodologies * Knowledge of data integrity and 21 CFR Part 11 compliance * Ability to work independently and in cross-functional teams * Travel flexibility for validation activities In this role you plan, execute, and document validation across equipment, processes, and computer systems to ensure product quality and regu... #J-18808-Ljbffr

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