Senior CSV / GxP IT Infrastructure Validation Engineer

Job Summary

Key Responsibilities

Required Skills

Preferred

Support validation of servers, networks, virtualization, manufacturing systems, and other infrastructure supporting regulated systems.

Assess GxP and validation impact of network, server, software, and configuration changes.

Support validation of Windows servers, VMware, Active Directory, firewalls, switches, VLANs, databases, backups, and interfaces.

Review system/network architecture, data flows, interfaces, ports, and protocols.

Support GxP infrastructure for SCADA, DCS, PLC, MES, BMS, EMS, LIMS, and laboratory systems.

Create and review validation documents including URS, risk assessments, GxP impact assessments, IQ/OQ, test scripts, RTM, and validation reports.

Apply GAMP 5, CSA, 21 CFR Part 11, EU Annex 11, Data Integrity, and ALCOA+ principles.

Support change controls, deviations, CAPAs, periodic reviews, audits, and validated-state maintenance.

Partner with IT, OT, Quality, Engineering, Automation, and Manufacturing teams.

8+ years in CSV, CSA, IT infrastructure validation, or GxP computerized systems.

Strong knowledge of GMP and computerized system lifecycle management.

Hands-on understanding of TCP/IP, VLANs, firewalls, DNS/DHCP, Active Directory, Windows Server, VMware, routing, and network segmentation.

Experience validating infrastructure supporting regulated manufacturing or laboratory systems.

Strong knowledge of GAMP 5, CSA, 21 CFR Part 11, EU Annex 11, and ALCOA+.

Experience with risk assessments, change control, deviations, CAPA, and periodic reviews.

Strong technical documentation and communication skills.

Pharmaceutical manufacturing experience, IT/OT infrastructure, cybersecurity/patching, disaster recovery, infrastructure migrations, and cloud/hybrid GxP environments are preferred.