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Csv engineer

Tondela
ALTEN
Anunciada dia 17 abril
Descrição

ALTEN Portugal, a leading force in the IT, Engineering and Life Sciences industries. We are currently seeking a dedicated and detail-orientedCSV Engineerto join our dynamic team in the Life Sciences division.ALTEN GroupWithin 30 years, ALTEN has become leader in both outsourced Engineering and IT Enterprise Services. ALTEN, composed of 54,000 employees (88% engineers), carries out complex and highly technical projects throughout the value chain of 6,500 clients, the most prestigious companies in all sectors of industry, services and telecommunications. We work with key actors in the Aeronautics & Space, Defense & Naval, Security, Automotive, Rail, Energy, Life Sciences, Finance, Retail, Telecommunications and Services sectors.Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?As aCSV Engineer,you will be responsible for ensuring that computerized systems are validated and maintained in compliance with GxP regulatory requirements. You will oversee the full validation lifecycle, including documentation, risk assessments, and testing activities, while ensuring adherence to Data Integrity principles such as ALCOA+. Key Responsibilities: Execute Computer System Validation (CSV) activities in compliance with GxP regulations. Ensure adherence to Data Integrity principles (ALCOA+). Author and review validation documentation: URS, FS, DS, IQ, OQ, PQ. Assess and validate computerized systems (e.g., LIMS, ERP, MES). Identify and mitigate risks related to data integrity. Collaborate cross-functionally with QA, IT, and Manufacturing teams. Ensure compliance with regulations such as 21 CFR Part 11 and Annex 11. Support change control and CAPA processes.Qualifications: Degree in Engineering, Pharmacy, Life Sciences, or related field. Proven experience in CSV and/or Data Integrity within a GxP environment. Strong knowledge of regulatory requirements (FDA, EU GMP). Hands-on experience with systems such as LIMS, ERP, or laboratory platforms. Familiarity with risk-based validation frameworks (e.g., GAMP 5). Strong documentation skills and attention to detail. Fluent in English. Ability to work effectively in multidisciplinary teams and collaborate on technical reviews without direct leadership responsibilities. Strong analytical and problem-solving skills, with attention to technical details and documentation accuracy.Location:Hybrid, Tondela.Why Join Us?Possibility to work with cutting-edge technology in the Life Sciences industry Collaborative and dynamic work environment Possibility to join a top-leading company in the industry Continuous trainings Possibility to join different and interesting projectsIf you want to embrace in a new and challenging opportunity and are excited about the opportunity to contribute to our team, we want to hear from you! Please submit your resume and cover letter detailing your relevant experience and qualifications.

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