Process Validation Specialist II
2 settimane fa
As a Process Validation Specialist II at Thermo Fisher Scientific, you will be responsible for evaluating manufacturing process documents and equipment cleaning procedures to ensure validation purposes. You will develop protocols and conduct process validation for product manufacturing and aseptic filling, as well as perform cleaning validation of cleaning procedures and ensure periodic cleaning verification.
Key Responsibilities
- Evaluate manufacturing process documents and equipment cleaning procedures for validation purposes
- Develop protocols and conduct process validation for product manufacturing and aseptic filling
- Perform cleaning validation of cleaning procedures and ensure periodic cleaning verification
- Manage validation protocols for cleaning, process, and Media Fill
- Collaborate with other departments to define protocol contents and actions to be carried out
- Validate manufacturing processes, cleaning procedures, and APS/Media Fill
- Support the drafting and approval of documents for new product transfer and validation
- Handle deviations related to validation activities
- Ensure accurate execution of validation activities and detailed analysis of results
- Draft validation reports and ensure proper archiving of all documentation
- Provide quality support for new product transfer and process qualification
- Actively participate in the design, construction, and implementation of new processes or manufacturing departments
Requirements
- 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
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