GxP IT CSV Specialist: Validation & Compliance (Hybrid)

MoonLake Immunotherapeutics (NASDAQ: MLTX); Porto; Híbrido; EUR 40 000 - 65 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Learning Environment

Impactful Work

Flexibility and Balance

Career Growth

Resumo da oferta

MoonLake Immunotherapeutics is seeking a Specialist IT CSV to ensure that GxP-regulated IT systems are validated, documented, and maintained in compliance with industry standards. You will support audit readiness and collaborate with IT, QA, and business teams.

The role emphasizes risk-based validation, vendor oversight, and cross-functional coordination in a biotech environment, with a hybrid work setup including Porto offices.

Qualificações

• Bachelor’s degree in information technology, Computer Science, Life Sciences, or a related field - or proven experience in CSV.
• Minimum 3-5 years of IT Computer System Validation experience in Biotech/Pharma is a plus.

Responsabilidades

• Lead and support full validation lifecycle for GxP IT systems, including planning, execution, change control, and documentation.
• Develop and execute validation protocols, risk assessments, and test plans for systems subject to GxP, SOX, ISO27001.
• Oversee vendor validation and computer system assurance activities for compliance.
• Maintain comprehensive validation documentation to ensure audit readiness.
• Coordinate periodic and retrospective reviews to confirm continued compliance and data integrity.
• Act as SME during audits and regulatory inspections, providing validation evidence.

Conhecimentos

CSV knowledge

SaaS/cloud systems

Vendor qualification

Veeva/SAP familiarity

Regulatory frameworks (EU Annex 11, 21

Formação académica

Bachelor’s degree in IT/CS/Life Sciences or equivalent

Ferramentas

Veeva

SAP

Descrição da oferta de emprego

MoonLake Immunotherapeutics is seeking a Specialist IT CSV to ensure that GxP-regulated IT systems are validated, documented, and maintained in compliance with industry standards. You will support audit readiness and collaborate with IT, QA, and business teams.

The role emphasizes risk-based validation, vendor oversight, and cross-functional coordination in a biotech environment, with a hybrid work setup including Porto offices.