Computer Systems Validation IT Engineer

About the role

The CSV IT Engineer at Corbion is responsible for ensuring that computerized systems used in Corbion-regulated environments comply with applicable Good Manufacturing Practice (GMP) regulations, data integrity standards, and validation requirements. This role involves leading and executing the full Computer System Validation (CSV) lifecycle for GxP-regulated computerized systems, developing and maintaining validation documentation, and supporting regulatory inspections and audits.

Responsibilities

• Provide daily IT operations support, including end-user support, desktop deployments, service management activities, and general IT support across Company locations.
• Lead and execute the full Computer System Validation (CSV) lifecycle for GxP-regulated computerized systems, ensuring systems remain in a validated state through implementation, operation, maintenance, periodic review, and retirement.
• Develop, execute, and maintain validation documentation, including validation plans, risk assessments, traceability matrices, test protocols/scripts, validation summary reports, and validation records.
• Validate and support regulated systems, including SCADA/HMI systems, historian platforms, laboratory systems (LIMS), cloud-based GxP applications, and related infrastructure.
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+ Data Integrity principles, GMP requirements, and Company quality standards.
• Perform risk assessments using GAMP 5 methodologies and evaluate system security, audit trails, electronic signatures, user access controls, and data integrity controls.
• Manage validation impacts associated with system changes, including change controls, regression testing, requalification activities, deviations, CAPAs, and remediation efforts.
• Coordinate validation activities and deliverables with vendors, third-party integrators, and internal stakeholders.
• Support regulatory inspections, customer audits, and internal compliance reviews, including addressing audit findings and implementing corrective actions.
• Support disaster recovery, backup validation, and business continuity testing to ensure compliance and operational readiness.
• Partner with Quality Assurance, Manufacturing, Engineering, Automation, Infrastructure, Cybersecurity, and business teams to ensure compliant system implementation and operation.
• Provide compliance and validation guidance during system implementations, upgrades, and enhancements.
• Train end users on validated procedures, compliance requirements, and data integrity expectations.
• Maintain GMP systems, backups, and data integrity controls while supporting ongoing system maintenance, upgrades, and continuous improvement initiatives.

Requirements

• Associate's degree in Computer Science, Engineering, Biotechnology, Pharmaceutical Sciences, Automation Engineering, or related discipline.
• 5+ years in IT Infrastructure and pharmaceutical, biotechnology, medical device, or regulated healthcare environments.
• Extensive experience and proven track record of CSV lifecycle management, GMP environments, and regulatory audits.
• Technical Skills: Validation & Compliance (GAMP 5, FDA 21 CFR Part 11, Annex 11, Data Integrity principles); IT & Infrastructure experience (VMware, Veeam Backups and Replication, Microsoft End User Computing, Windows Server, Active Directory, SQL/Postgres databases, Cloud technologies, Cisco LAN and Wireless).
• Prior certifications: VMware VCP-DCV + VCP-VCF, Veeam Certified Engineer VMCE, Microsoft MCP, ITIL, Cisco LAN and WLAN technologies, ISPE GAMP Certification.
• Excellent technical writing and detail-oriented mindset.
• Analytical problem-solving skills.
• Exceptional communication skills.
• Excellent time management and prioritization.

Preferred Qualifications

• Preferably certified in ISPE GAMP Certification.

Pay

The anticipated compensation range for this position is $96,000 to $115,000. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type years of and experience within the industry, education, etc.

Benefits

• Bonus potential
• Paid time off, including company holidays
• 401K with company match
• Medical, dental, vision and basic life insurance coverage are offered to employees and eligible dependents (provided they meet eligibility requirements)
• Flexible spending accounts
• Education assistance
• Short- and long-term disability
• Employee Assistance Program (EAP)
• Lifestyle and wellness benefits

About Corbion

Corbion is a sustainable ingredients company dedicated to preserving what matters, including food and food production, health, and the planet. We specialize in lactic acid, lactic acid derivatives, food preservation solutions, functional blends, and algae ingredients, using our deep application and product knowledge to propel nature’s ingenuity through science. With more than a century of experience, we continue working side-by-side with our customers to make our cutting-edge technologies work for them. Leveraging our advanced capabilities in fermentation and preservation technology, we help customers differentiate their products in diverse markets ranging from food and animal nutrition to home & personal care, pharmaceuticals, electronics, medical devices, and bioplastics. In 2025, Corbion generated annual sales of € 1,267.4 million with a workforce of 2,408 FTEs. Corbion is listed on Euronext Amsterdam. For more information: www.corbion.com

Equal Opportunity Employer

Corbion is an equal opportunity employer and committed to a diverse workplace. All applicants will be considered equally without regard to race, color, ethnicity, veteran status, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, handicapping condition, membership in an organization or any other non-merit factors. Corbion provides reasonable accommodation to applicants. EOE/M/F/Vet/Disabled