Validation Analyst Job Details

At Guerbet, we build lasting relationships so that we enable people to live better .

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in contrast products for the last 95 years, we continuously innovate.

Customer centricity , Cooperation , Audacity , Focus , and Responsibility are the values that we share and practice .

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on LinkedIn, X , Instagram, and YouTube .

WHAT WE'RE LOOKING FOR

We are looking for a proactive and detail-orientedComputerized Systems Validation Analyst (Pleno level)to join our Quality department. In this role, you will ensure compliance with ANVISA RDC 658, IN 134/22, IN 138/22, and international guidelines by validating computerized systems and supporting continuous improvement initiatives. You will also contribute to audits, inspections, and global projects, playing a key role in maintaining the integrity of our validation processes.
This position is based in Rio de Janeiro, is a fully on-site role, and is a full-time position.

YOUR ROLE

• Validate both legacy and new computerized systems.

• Maintain and update the Computerized Systems Validation Master Plan and Inventory.

• Prepare full lifecycle documentation: planning, risk analysis, functional/technical specifications, qualification protocols, final reports, and periodic reviews.

• Support and improve BPx system areas.

• Evaluate change requests and CAPAs related to system validation.

• Assist in deviation investigations and CAPA processes.

• Conduct audits to ensure validated status of embedded BPx systems.

• Participate in inspections and audits related to computerized systems validation.

• Support Federal Revenue audits to maintain OEA certification.

• Present EHS topics monthly in DDS meetings and engage in global projects.

YOUR BACKGROUND

Education
Degree in Pharmacy, Systems Analysis, Chemistry, or Chemical Engineering.

Experience
At least 2 years of experience in Computerized Systems Validation.

Skills/Competencies

• Advanced knowledge in computerized systems validation

• Intermediate English proficiency

• Proficiency in Microsoft Office (Word, Excel, Visio, PowerPoint)

• Desirable: Knowledge of PLC, HMI, basic programming, IT infrastructure, application servers, and databases

• Self-confidence, teamwork, organization, focus, interpersonal skills, and proactivity

O QUE ESTAMOS PROCURANDO

Estamos em busca de um(a)Analista de Validação de Sistemas Computadorizados Plenoproativo(a) e detalhista para integrar o nosso departamento de Qualidade. Você será responsável por garantir a conformidade com a RDC 658 da ANVISA, IN 134/22, IN 138/22 e guias internacionais, por meio da validação de sistemas computadorizados e apoio a iniciativas de melhoria contínua. Também atuará em auditorias, inspeções e projetos globais, assegurando a integridade dos nossos processos de validação.
Esta vaga está localizada no Rio de Janeiro, é uma posição totalmente presencial e em tempo integral.

SUA FUNÇÃO

• Validar sistemas computadorizados legados e novos.

• Manter atualizado o Plano Mestre de Validação e o Inventário de Sistemas.

• Elaborar documentação completa do ciclo de vida: planejamento, análise de risco, especificações, protocolos de qualificação, relatórios finais e revisões periódicas.

• Apoiar e melhorar continuamente as áreas responsáveis pelos sistemas BPx.

• Avaliar solicitações de mudança e ações corretivas/preventivas relacionadas à validação.

• Apoiar investigações de desvios e processos de CAPA.

• Realizar auditorias para garantir o status validado dos sistemas embarcados BPx.

• Participar de inspeções e auditorias relacionadas à validação de sistemas.

• Apoiar auditorias da Receita Federal para manutenção da certificação OEA.

• Apresentar temas de SSMA mensalmente nas reuniões de DDS e participar de projetos globais.

SEU PERFIL

Formação Acadêmica
Graduação em Farmácia, Análise de Sistemas, Química ou Engenharia Química.

Experiência
Mínimo de 2 anos na área de Validação de Sistemas Computadorizados.

Habilidades/Competências

• Conhecimento avançado em validação de sistemas computadorizados

• Inglês intermediário

• Domínio do pacote Office (Word, Excel, Visio, PowerPoint)

• Desejável: Conhecimento em PLC, IHM, noções de programação, infraestrutura de TI, servidores de aplicação e banco de dados

• Autoconfiança, trabalho em equipe, organização, foco, bom relacionamento interpessoal e proatividade

EQUAL EMPLOYMENT OPPORTUNITY

Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant based on race, color, religion, national origin, sex, age, disability, veteran or military status, genetic information, pregnancy or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.

Applicants may be entitled to reasonable accommodation due to disability, pregnancy or related medical condition, or a sincerely held religious belief. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing an undue hardship on Guerbet. Please inform the company's personnel representative if you need assistance completing this application or to otherwise participate in the application process.

Guerbet will not discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.