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

At Corbion we exist to champion preservation in all its forms preserving food and food production health and our planet.

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 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.

Key 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.

Required Qualifications

• Associates 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.
• Preferred Certifications: VMware VCP-DCV VCP-VCF Veeam Certified Engineer VMCE Microsoft MCP ITIL Cisco LAN and WLAN technologies and ISPE GAMP Certification.
• Excellent technical writing and detail-oriented mindset .
• Analytical problem-solving.
• Exceptional communication skills
• Excellent time management and prioritization

Our offer

The anticipated compensation range for this position is $96000 to $115000. 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. Please note Corbion is a multi-state employer and this pay scale may not reflect positions that work in other states or addition to the base compensation we offer the following 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

*Please note this is intended to provide a general description of benefits and other compensation and is not a substitute for applicable plan documents or company policies. Eligibility requirements for these benefits will be controlled by applicable plan documents.

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 natures 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 2025 Corbion generated annual sales of 1267.4 million with a workforce of 2408 FTEs. Corbion is listed on Euronext Amsterdam. For more information:

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

Corbion does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers. All candidates must be submitted by approved Corbion vendors who have been expressly requested to make a submission by our Talent Acquisition team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Corbion Talent Acquisition team and such candidate was submitted to the Corbion Talent Acquisition Team.