IT CSV Engineer

As Senior IT CSV Engineer at HAL Allergy, you play a critical role in ensuring that computerized systems supporting GxP processes remain compliant, secure, and fit for intended use throughout their lifecycle. You act as the bridge between IT, Validation, Quality, and business stakeholders, ensuring that system implementations and changes are delivered efficiently without compromising compliance.

You combine strong technical expertise with extensive validation experience and are responsible for the IT side of qualification, verification, validation, and change management activities. Through a pragmatic, risk-based approach, you help drive efficient system delivery while maintaining regulatory compliance and data integrity standards. Your tasks

• Lead IT validation activities for new systems and system changes from initiation through validated go-live.
• Perform risk assessments (e.g., FMEA) and define validation strategies using CSA and GAMP 5 principles.
• Author and maintain validation documentation, including Validation Plans, IQ/OQ protocols, UAT documentation, SOPs, and Validation Summary Reports.
• Execute and coordinate qualification, verification, validation, and configuration review activities.
• Validate on-premises infrastructure, cloud platforms, and SaaS applications.
• Manage system changes, impact assessments, patching, and re-validation activities through the change management process.
• Ensure compliance with GxP, Annex 11, ALCOA++, and data integrity requirements.
• Support supplier qualification, audits, inspections, deviations, CAPAs, and periodic system reviews.
• Drive continuous improvement through automation, standardization, and risk-based validation practices.

• Bachelor's or Master's degree in IT, Computer Science, Information Systems, or a related field.
• 5+ years of CSV experience within the pharmaceutical, biotech, or life sciences industry.
• Strong knowledge of GxP, EU Annex 11, ALCOA++, CSA, and GAMP 5.
• Experience with IQ/OQ, UAT, validation documentation, and computerized system lifecycle management.
• Solid technical understanding of IT infrastructure, cloud technologies (Azure), networking, and identity & access management.
• Experience with cloud and SaaS validation in regulated environments.
• Strong stakeholder management, communication, and documentation skills.
• Professional proficiency in Dutch and English., You are a hands-on validation professional who enjoys working where technology, compliance, and innovation come together. You have a strong technical foundation, but also understand the importance of quality, regulatory compliance, and business needs in a GxP environment.

You are naturally curious, challenge the status quo, and apply a pragmatic, risk-based approach to solving complex problems. Whether leading a risk assessment, discussing technical solutions with IT teams, or partnering with Quality and Validation colleagues, you are able to build trust and drive decisions.

You thrive in a dynamic environment where no two projects are the same, take ownership of your work, and enjoy improving processes through automation and smart ways of working. Most importantly, you are passionate about delivering compliant, reliable systems that support patients, products, and business success. Our offer

• You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
• A culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient's well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
• You will be working in our dynamic headquarters in Leiden, where we work on the full project pipeline from development to commercial production.
• Being part of a company that is geared towards helping people live happier and healthier lives.
• A competitive salary that matches your responsibilities and experience.
• A 13th month salary
• 30 leave days.
• Company contribution to a pension package and health insurance.

HAL Allergy, for those who seek pharmaceutical innovation HAL Allergy is one of the European top players in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We focus on the development and manufacturing of modified allergen extracts for the therapeutic and diagnostic purposes of respiratory and food allergies. With all our activities the patient's well-being is always top of mind. At Hall Allergy we foster open discussions, an entrepreneurial spirit and close collaborations within the teams and with our international colleagues summing up to more than 300 highly specialized people across various positions. If you too would like to become a part of an innovative and challenging pharmaceutical manufacturer, then this is your perfect opportunity! HAL Allergy is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HAL Allergy is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.