Join a leading multinational biotech company dedicated to transforming scientific breakthroughs into life-saving therapies. As a CSV Engineer, you'll ensure computerized systems in GMP-regulated settings meet all validation requirements. Engage in diverse projects, collaborate with IT and QA teams, and support audits. Enjoy the dynamic environment while contributing to impactful health solutions. Excited to connect with passionate professionals! Take the next step and explore why this role is a great fit for you.

Over het bedrijf

SIRE Life Sciences

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The Company
Our client is a multinational biotech company who strives to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives.

Role Description
As a CSV Engineer, you will be responsible for ensuring that computerized systems used in GMP-regulated environments are validated in compliance with applicable regulatory requirements. You will lead or support validation efforts across the lifecycle of systems, including laboratory equipment, manufacturing systems, and quality systems software.

Responsibilities
- Develop, review, and execute validation deliverables (e.g., URS, Risk Assessments, IQ, OQ, PQ, validation plans and reports)
- Ensure systems are validated in accordance with GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and company policies
- Collaborate with IT, QA, and system owners to implement and maintain validated systems
- Support audits and inspections by providing documentation and responding to questions on validation activities
- Maintain validation documentation and ensure data integrity compliance
- Provide guidance on change control, periodic reviews, and system lifecycle management
- Participate in project teams for new system implementations or upgrades

Requirements
- Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or a related field
- 2–5 years of experience in Computer System Validation in the pharmaceutical or biotech industry
- Strong knowledge of applicable regulatory standards
- Experience with GMP environments and validated systems (e.g., LIMS, MES, ERP, SCADA)
- Analytical mindset with strong documentation and organizational skills
- Fluent in English (spoken and written); Dutch is a plus

Other information
Apply to our vacancy for more information. Looking forward to getting in touch!

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