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Process & Cleaning Validation Specialist II
2 mesi fa
Job Description
About Thermo Fisher Scientific Inc.
Thermo Fisher Scientific Inc. is a global leader in serving science, with a mission to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we are committed to accelerating research, solving complex scientific challenges, driving technological innovation, and supporting patients in need. We value diverse experiences, backgrounds, and perspectives, and foster a collaborative and inclusive work environment.
Process & Cleaning Validation Specialist II
As a Process & Cleaning Validation Specialist II at Thermo Fisher Scientific, you will have the opportunity to be part of a world-class team and contribute to the flawless validation of manufacturing processes and cleaning procedures. Your expertise and proven experience will play a crucial role in ensuring the production of high-quality pharmaceutical products that meet strict regulatory requirements.
Responsibilities:
- Evaluate manufacturing process documents and equipment cleaning procedures for validation purposes
- Develop protocols and conduct process validation for product manufacturing and aseptic filling (Media fill)
- 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
