Process & Cleaning Validation Specialit I

13 ago - Italia
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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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