Computer Systems Validation (CSV) IT Engineer (IT Support Specialist)

corbion • Tucker, GA

8d • $96,000 - $115,000 • Onsite

About The Position

The CSV IT Engineer 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. In this role, you will support the validation lifecycle of GxP systems, including infrastructure, applications, cloud environments, manufacturing systems, laboratory systems, and quality systems. You will be a part of the global Corbion IT organization as a full-time onsite position, based in Tucker, Georgia. Works closely with Regional & Global IT, Quality Assurance (QA), Manufacturing, Engineering, Automation, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with FDA and other Corbion regulatory expectations. This position is critical in maintaining validated states for computerized systems and ensuring compliance with regulations of: 21 CFR Part 11, GAMP 5, ALCOA+ Data Integrity principles, FDA GMP requirements, Corbion Service Management SLA and quality standards.

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, and Data Integrity principles
• IT & Infrastructure experience: VMware, Veeam Backups and Replication, Microsoft End User Computing, Windows Server, Active Directory, SQL/Postgres databases, Cloud technologies, and Cisco LAN and Wireless proven skills.
• Excellent technical writing and detail-oriented mindset.
• Analytical problem-solving.
• Exceptional communication skills,
• Excellent time management and prioritization

Nice To Haves

• Preferred Certifications: VMware VCP-DCV + VCP-VCF, Veeam Certified Engineer VMCE, Microsoft MCP, ITIL, Cisco LAN and WLAN technologies, and ISPE GAMP Certification.

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.
• Monitor GMP systems, backups, and data integrity controls while supporting ongoing system maintenance, upgrades, and continuous improvement initiatives.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree