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 purposesDevelop protocols and conduct process validation for product manufacturing and aseptic filling (Media fill)Perform cleaning validation of cleaning procedures and ensure periodic cleaning verificationManage validation protocols for cleaning, process, and Media FillCollaborate with other departments to define protocol contents and actions to be carried outValidate manufacturing processes, cleaning procedures, and APS/Media FillSupport the drafting and approval of documents for new product transfer and validationHandle deviations related to validation activitiesEnsure accurate execution of validation activities and detailed analysis of resultsDraft validation reports and ensure proper archiving of all documentationProvide quality support for new product transfer and process qualificationActively participate in the design, construction, and implementation of new processes or manufacturing departments

Requirements:Bachelor's Degree or equivalent in a scientific/pharmaceutical area2 years of previous related experience in the pharmaceutical sectorKnowledge of pharmaceutical techniques, production, and aseptic filling processesExperience in risk management and client service/project managementProficiency in Microsoft Office softwareFluent in English with advanced written and oral communication skills