Moonlaketx·14 days ago
14 days ago
Specialist IT CSV
Sign up free to see how well your resume matches this role.
What you'll do
- 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.
- 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.
- Oversee and review vendor validation and computer system assurance activities and due diligence to ensure compliance with internal and external requirements.
- Maintain comprehensive validation documentation, ensuring systems are audit-ready and compliant throughout their lifecycle.
- 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.
- Act as a subject matter expert during audits and regulatory inspections, providing validation evidence and guidance.
- 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.
- Provide training and guidance on CSV processes, documentation, and regulatory requirements to relevant stakeholders.
What they're looking for
- 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
- CSV Knowledge.
- Experience with SaaS/cloud-based systems and vendor qualification.
- Understanding of international regulatory frameworks such as EU Annex 11, FDA 21 CFR Part 11, ICH E6(R3), GAMP, PICs, ISO/IEC 27001, ISO9001.
- Excellent documentation, problem-solving, and communication skills.
- Ability to work collaboratively in a fast-paced, dynamic environment.
Nice to have
- Experience within Biotech or Pharmaceutical
- Familiarity with systems such as Veeva, SAP, or similar platforms
- GxP and SOX experience
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Job Purpose
Your profile
Why us?
Company
Moonlaketx
PT
Company facts come from this company's own listings. We only show what the postings themselves carry.