Senior Validation Analyst – Focus on Cleaning Validation (Pharmaceutical Technology Specialist II)

Job Description: Senior Validation Analyst – Focus on Cleaning Validation.

We are seeking a Senior Validation Analyst with focus on cleaning validation, degree in Pharmaceutical Sciences, Chemistry or Engineering, to work on the development of documents related to process and cleaning validation, supplier qualification, and technology transfer. This professional will have as main objective ensuring product quality and process robustness, meeting GxP standards, national and international regulatory requirements, and EHS guidelines.

The Senior Analyst will be the focal point for all activities related to the lifecycle of cleaning validation at the site, in addition to providing support in deviation investigations and evaluation of changes that may affect GxP. We expect the candidate to demonstrate high proactivity, problem-solving capacity, and ease of interaction with support areas.

It is essential to possess knowledge of regulatory agency standards for defining requirements, mastery in statistics for trend analysis and development of corrective or preventive action plans, as well as experience with risk analysis tools applied to process validation mapping. Experience in aseptic processes, ability to develop and apply technical training, and knowledge of process and cleaning validation liquid and suspension forms will be considered a plus. Familiarity with pharmaceutical technology, sterile processes, and aseptic techniques such as media fill and media hold is also desirable.

The requirements for the position include a degree in Pharmaceutical Sciences, Chemistry or Engineering, advanced English (C1 level) and at least three years of experience in Validation in the Pharmaceutical Industry.