Csv engineer (lifesciences & medical devices)

Sobre a vaga

Plan, define, and execute Computer System Validation activities in compliance with GxP guidelines. You will develop and maintain validation documentation for innovative companies in the Lifesciences and Medical Devices sector.

O que vais fazer

• Plan, define, and execute Computer System Validation (CSV) activities in compliance with GxP guidelines (e.g., GAMP5, FDA, EMA)
• Develop and maintain validation documentation, including:
• Validation Plans (VP)
• User Requirement Specifications (URS)
• Functional and Design Specifications (FS/DS)
• IQ/OQ/PQ protocols and reports

O que é pedido

• Academic background in Pharmaceutical Sciences, Life Sciences, Engineering, or a related field, ensuring understanding of regulated environments and industry practices
• Strong experience in Computer System Validation (CSV) within regulated environments (pharmaceutical, biotech), with solid knowledge of GxP, GAMP5, and compliance standards
• Proven ability to translate business and regulatory requirements into validation deliverables, ensuring full traceability and high-quality documentation
• Hands-on expertise in validation lifecycle activities (URS, FS/DS, IQ/OQ/PQ) combined with a structured and detail-oriented approach
• Comfortable working in international, multicultural teams, with strong communication skills and fluency in English

O que é oferecido

• Join a multicultural and inclusive team environment
• Enjoy a supportive atmosphere promoting work life balance
• Hybrid work
• Your career growth is central to our mission
• Our array of career growth programs and diverse professionals are crafted to support you in exploring a world of opportunities
• Access valuable training and certifications in cutting edge technologies
• Engage in exciting national and international projects
• Health and life insurance
• Referral program with bonuses for talent recommendations
• Great office locations

Resumo organizado por IA a partir do anúncio original. Confirma os detalhes no site da empresa.

Benefícios e vantagens

• Acções da empresa
• Comida, fruta e bebida
• Flex benefits
• Flexibilidade de horário
• Mais de 22 dias de férias
• Programa de descontos
• Seguro de saúde
• Suporte psicológico

Valores e cultura

• Ambiente internacional
• Crenças e religião
• Híbrido
• Igualdade de género
• Igualdade racial
• Incentivo à criatividade & inovação
• LGBTQ+ friendly
• Pessoas portadoras deficiência / incapacidade permanente
• Tecnologias de ponta