Lavori attuali relativi a Process Validation Specialist - Ferentino, Lazio - Thermo Fisher Scientific
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Ferentino, Lazio, Italia Thermo Fisher Scientific A tempo pienoJob SummaryWe are seeking a highly skilled Process and Cleaning Validation Specialist II to join our team at Thermo Fisher Scientific. In this role, you will be responsible for evaluating manufacturing process documents and equipment cleaning procedures to ensure compliance with regulatory requirements.Key ResponsibilitiesEvaluate manufacturing process...
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Process Validation Specialist
2 mesi fa
We are seeking a highly skilled Process & Cleaning Validation Specialist II to join our team at Thermo Fisher Scientific. As a key member of our validation team, you will be responsible for ensuring the accuracy and reliability of our manufacturing processes and cleaning procedures.
Key Responsibilities- Evaluate and validate manufacturing process documents and equipment cleaning procedures to ensure compliance with regulatory requirements.
- Develop and implement process validation protocols for product manufacturing and aseptic filling, including media fill validation.
- Perform cleaning validation of cleaning procedures and ensure periodic cleaning verification to maintain a high level of quality and safety.
- Manage validation protocols for cleaning, process, and media fill, ensuring timely completion and accuracy of results.
- Collaborate with cross-functional teams to define protocol contents and actions to be carried out, ensuring seamless execution and delivery.
- Validate manufacturing processes, cleaning procedures, and APS/media fill to ensure compliance with regulatory requirements and company standards.
- Support the drafting and approval of documents for new product transfer and validation, ensuring accuracy and completeness of information.
- Handle deviations related to validation activities, ensuring prompt resolution and documentation of issues.
- Ensure accurate execution of validation activities and detailed analysis of results, providing recommendations for process improvements.
- Draft validation reports and ensure proper archiving of all documentation, maintaining a high level of organization and record-keeping.
- Provide quality support for new product transfer and process qualification, ensuring seamless integration and delivery.
- Bachelor's Degree or equivalent in a scientific/pharmaceutical area.
- 2 years of previous related experience in the pharmaceutical sector.
- Knowledge of pharmaceutical techniques, production, and aseptic filling processes.
- Experience in risk management and client service/project management.
- Proficiency in Microsoft Office software.
- Fluent in English with advanced written and oral communication skills.
