Global IT Infrastructure CSV/CSA Expert

Curium Pharma; Schagen; On-site; EUR 54,730 - 80,366; Full time

Benefits offered by this job

Holiday allowance

13th month salary

Bonus scheme

Job summary

A global healthcare company based in Schagen is seeking a Global IT Infrastructure CSV/CSA Expert to ensure the reliability and compliance of IT systems in the healthcare sector. The role involves preparing validation documentation, conducting audits, and training colleagues on compliance standards. A bachelor's degree in IT or a related field and several years of experience in IT compliance and data integrity is required. The position offers a competitive salary and the opportunity to impact patient safety globally.

Qualifications

• Several years of experience in CSV/CSA, data integrity, and IT compliance.
• Knowledge of GxP, EU Annex 11, 21 CFR Part 11.
• Understanding of IT infrastructure including cloud and data flows.
• Fluent in English; Dutch is important for local communication.

Responsibilities

• Prepare and execute validation and qualification documentation.
• Perform risk-based analyses for IT compliance.
• Ensure compliance with FDA and EU regulations.
• Conduct internal and external audits and inspections.
• Train global IT colleagues on compliance procedures.

Skills

CSV/CSA

Data integrity

IT compliance

Strong communication skills

Curiosity about technology

Education

Bachelor’s degree in IT, Engineering, Computer Science, or Life Sciences

Job description

Imagine a workday where you ensure that the IT infrastructure and supporting systems behind manufacturing and data are demonstrably reliable. Where you identify risks, co-create test plans, and guide colleagues in keeping our IT infrastructure and supporting systems secure and compliant.

Work that may be invisible to the outside world — yet essential to the quality of medicines and, ultimately, to patient safety worldwide.

That is exactly what energizes our Global IT Compliance team every day: making sure technology not only works but is also demonstrably compliant.

Due to the growth of our organization and the upcoming retirement of a colleague, we are looking for a Global IT Infrastructure CSV/CSA Expert to take on this crucial role. Your scope will cover global IT infrastructure and the systems that support it.

At Curium, you indirectly contribute to nuclear medicine that helps millions of patients worldwide — and you ensure that the IT foundations beneath it are just as reliable as the medicines themselves.

Key Responsibilities

Global IT Infrastructure CSV/CSA Expert

• Prepare, review, and execute (or coordinate the execution of) validation and qualification documentation for global IT infrastructure and supporting IT systems.
• Perform risk-based analyses (CSA): what do we test, to what depth, and why?
• Coordinate qualifications and validations (e.g., IQ/OQ/PQ) and assess test results.

Compliance & Regulations

• Ensure global IT infrastructure and supporting IT systems to comply with regulations such as FDA 21 CFR Part 11 and EU cGMP guidelines (specifically Annex 11).
• Translate new or updated regulations into practical IT measures.
• Contribute to an effective IT compliance program.
• Support internal and external audits and inspections.
• Coordinate and follow up on CAPAs and deviations related to the global IT infrastructure.
• Ensure corrective and improvement actions are structurally implemented.
• Align IT infrastructure qualification policies globally with site-specific departments.
• Train global IT colleagues on procedures, qualification and validation approaches, and IT compliance guidelines.
• Create awareness around IT compliance across the organization.

Documentation & Governance

• Establish and maintain controlled documentation and repositories.
• Ensure global IT infrastructure qualification and supporting validation documentation are complete and up to date.

What We Offer

• Salary range: EUR 54.730 - EUR 80.366 gross per year, depending on knowledge and experience.
• Holiday allowance, 13th month, and bonus scheme.
• An international, highly specialized environment with a high societal impact.

Education & Experience

Do you have a Bachelor’s level working and thinking capability (HBO level) in IT, Engineering, Computer Science, Life Sciences, or a related field — and experience with IT infrastructure qualification and validation in a regulated environment? If so, we would love to connect with you.

We are looking for someone who brings:

• Several years of experience in CSV/CSA, data integrity, and IT compliance.
• Has knowledge of GxP, EU Annex 11, 21 CFR Part 11 (or comparable regulations).
• Understands IT infrastructure (e.g., cloud, systems, data flows).
• Possesses strong communication skills and can engage stakeholders effectively.
• Is curious about technology and IT developments.

Fluency in English is essential due to international collaboration. Dutch is important for local procedures and communication in Petten.

What Does Our Team Look Like?

As a Global IT Infrastructure CSV/CSA Expert, you will become part of the Global IT Compliance team — an international group of specialists focused on IT risk, compliance, and qualification and validation of global IT infrastructure.

We collaborate closely with location-based IT, Quality, and business departments worldwide. The culture is highly knowledgeable yet approachable: we support each other, exchange ideas frequently, and work together to find practical solutions within complex regulatory frameworks.

You will have a high level of autonomy — but you will never stand alone.

Interested, or do you know someone who would be a great fit for this role? Apply now or refer to a candidate!