Regulatory IT CSV Specialist — Remote/Hybrid

MoonLake Immunotherapeutics; Pedrouços; Híbrido; EUR 45 000 - 65 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Learning environment

Hybrid/Remote flexibility

Career growth

Resumo da oferta

MoonLake Immunotherapeutics is seeking a Specialist IT CSV to lead validation lifecycles for GxP and regulated IT systems, ensuring compliant documentation and audit readiness. You will collaborate with IT, QA, and business teams to maintain data integrity and security across validated systems.

Responsibilities include risk assessments, protocol development, vendor oversight, and facilitating internal audits and inspections.

Qualificações

• Bachelor's degree or proven CSV experience.
• 3–5 years in IT Computer System Validation, Biotech/Pharma a plus.
• Familiar with GxP, SOX, EU Annex 11 and FDA 21 CFR Part 11 requirements.

Responsabilidades

• Lead and support full validation lifecycle for GxP IT systems, including planning, execution, change control, and documentation.
• Develop and execute validation protocols and risk assessments for regulated systems.
• Oversee vendor validation activities and due diligence for compliance.
• Maintain audit-ready validation documentation throughout the system lifecycle.
• Coordinate periodic and retrospective reviews to ensure continued compliance and data integrity.
• Support audits and regulatory inspections with validation evidence and guidance.
• Collaborate across IT, QA, Finance, Clinical Ops and vendors for compliance and security.

Conhecimentos

CSV Knowledge

SaaS/cloud experience

Vendor qualification

Regulatory knowledge

Formação académica

Bachelor's degree in IT/CS/Life Sciences or related field

Ferramentas

Veeva

SAP

Descrição da oferta de emprego

MoonLake Immunotherapeutics is seeking a Specialist IT CSV to lead validation lifecycles for GxP and regulated IT systems, ensuring compliant documentation and audit readiness. You will collaborate with IT, QA, and business teams to maintain data integrity and security across validated systems.

Responsibilities include risk assessments, protocol development, vendor oversight, and facilitating internal audits and inspections.