Process & Cleaning Validation Specialit I

10 ago - Ferentino
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.

La preghiamo di leggere attentamente i seguenti dettagli prima di inviare la sua candidatura.

- 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) xysqume
- 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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