VALIDATION ENGINEER

The Engineering Validation Specialist is responsible for planning, executing, documenting, and maintaining qualification activities for GMP equipment and utilities used in pharmaceutical manufacturing environments in compliance with applicable regulations (laws, GMP, FDA, etc.), Prepare, review, and maintain GMP documentation, including URS, DQ, IQ, OQ, PQ, qualification protocols, and final reports, in accordance with internal procedures and regulatory expectations. Ensure the analysis and evaluation of raw technical data and documentation related to equipment and instruments subject to qualification, in order to acquire the information necessary for defining procedures/protocols Coordinate qualification activities for manufacturing equipment, process systems, utilities, and laboratory instruments. Support Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT). Ensure qualification documentation is generated, reviewed, and archived in accordance with GMP requirements and data integrity principles. Collaborate with Engineering, Production, Quality Assurance, Validation, Maintenance, and external suppliers to ensure timely project completion Participate in regulatory inspections and customer audits, providing technical support and qualification documentation as required. Contribute to the development and continuous improvement of qualification procedures, templates, and validation strategies. In collaboration with the Purchasing Department, prepare requests for quotation to suppliers and support the Manager in preparing a technical and economic evaluation of the offers received. Bachelor's or Master's degree in a scientific or engineering discipline (e.g. Chemistry, Biotechnology, Engineering, Pharmacy). Minimum 2-3 years of experience in qualification and/or validation roles within pharmaceutical or biotechnology manufacturing environments, preferably in CDMO organizations. Solid knowledge of GMP and relevant international regulatory standards (EMA, FDA). Proven experience in the preparation and management of GMP documentation in regulated environments. Hands-on experience gained in pharmaceutical production areas utilizing isolator technology, particularly in aseptic and sterile Fill & Finish operations for biologics preferred. Knowledge of regulations related to Equipment and Utilities validation, with particular reference to sterile departments (for examples isolator, autoclave, tunnel, VHP). Excellent communication skills and ability to work effectively in cross-functional and client-facing environments. Good command of the English language (minimum B2 level). Proficiency in standard IT tools, including MS Office, document management systems. Are you looking for new challenges in a highly competitive environment? And you want to tackle them creativelyand on your own responsibility? We would be happy to explain our corporate benefits in a personalconversation Haupt Pharma Latina S.r.l. ~