Specialist IT CSV

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

Job Purpose

As a Specialist IT CSV, you will report to the Head of IT and play a critical role in ensuring that all IT-managed computerized systems - especially GxP-regulated and other critical systems (e.g., SOX, ISO27001) - are validated, documented, and maintained in compliance with applicable industry regulations and standards. Your work will support audit and inspection readiness, system and data integrity, and cross-functional collaboration across IT, Quality, and business teams. This is a dynamic opportunity for professionals who thrive in regulated environments and want to make a meaningful impact in biotech innovation.

Major Accountabilities

• Validation Lifecycle Management:Lead and support the full validation lifecycle for GxP and other regulated IT systems, including planning, execution, change control, documentation, periodic system reviews, retrospective system reviews when required, and continuous improvement.
• Protocol Development & Risk Assessment: Work with MoonLake system owners to develop and execute validation protocols, risk assessments, and test plans for systems subject to GxP, SOX, ISO27001, and related standards.
• Vendor Oversight:Oversee and review vendor validation and computer system assurance activities and due diligence to ensure compliance with internal and external requirements.
• Documentation & Audit Readiness:Maintain comprehensive validation documentation, ensuring systems are audit-ready and compliant throughout their lifecycle.
• Periodic and Retrospective Reviews:Coordinate and perform periodic reviews of validated and critical systems to confirm continued compliance, intended use, data integrity, access controls, change history, incident records, and vendor performance. Conduct retrospective system reviews when needed, such as after major changes, deviations, audit findings, business process changes, or when systems have not been reviewed or validated to the expected standard.
• Audit & Inspection Support:Act as a subject matter expert during audits and regulatory inspections, providing validation evidence and guidance.
• Cross-Functional Collaboration:Work closely with IT, QA, Finance, Clinical Operations, other departments and vendors to ensure ongoing compliance, data integrity, business continuity planning, disaster recovery, and security for all validated systems.
• Training & Guidance:Provide training and guidance on CSV processes, documentation, and regulatory requirements to relevant stakeholders.

Your profile

Education & Experience

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

Technical Skills

• CSV Knowledge.
• Experience with SaaS/cloud-based systems and vendor qualification.
• Familiarity with systems such as Veeva, SAP, or similar platforms is a plus.
• Understanding of international regulatory frameworks such as EU Annex 11, FDA 21 CFR Part 11, ICH E6(R3), GAMP, PICs, ISO/IEC 27001, ISO9001. GxP and SOX are a plus.

Personal Skills

• Excellent documentation, problem-solving, and communication skills.
• Ability to work collaboratively in a fast-paced, dynamic environment.

Work Location

• 2 days a week in our brand new Porto office.

Why us?

An exciting job opportunity awaits you!

MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.

What we offer:

Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.

Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.

Flexibility and Balance:Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.

Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.