Process & Cleaning Validation Specialist Ii

2 settimane fa

Lazio, Italia Thermo Fisher Scientific A tempo pieno

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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

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