Process & Cleaning Validation Specialist II

Work Schedule

Environmental Conditions

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