Process & Cleaning Validation Specialit I

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…

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