Validation Scientist

GMP Systems Administrator Validation Scientist Location: Wilson NC Schedule: Monday-Friday first shift Hourly Pay Rate: $40 Temporary to hire A leading commercial laboratory testing organization is seeking a GMP Systems Administrator Validation Scientist to oversee GMP software validations and lab IT system compliance across its regulated environments. This pivotal role ensures that all computerized systemsincluding laboratory instrumentation softwareare validated, compliant, and maintained in a controlled state per regulatory standards (FDA 21 CFR Part 11, EU Annex 11, GAMP 5). This position bridges IT system administration with quality and regulatory oversight, partnering with laboratory staff, QA teams, and vendors to implement, validate, and maintain systems for use in a GMP-compliant setting. Familiarity with chromatography data systems (e.g., Chromeleon, Empower, OpenLab) is highly desirable. Key Responsibilities: Lead and execute software validation activities (IQ, OQ, PQ) for lab systems including CDS, LIMS, and standalone instrument software. Maintain validation documentation in alignment with internal SOPs and regulatory requirements. Act as the subject matter expert for Computerized System Validation (CSV); support audits, inspections, and CAPAs. Ensure instrument PCs and lab systems are secure, validated, backed up, and compliant. Manage software deployment, configuration, and qualification of lab instruments (e.g., HPLC, GC, UV). Coordinate with QA and Lab Management to assess validation needs for changes to software or hardware. Provide Tier 2/3 support for laboratory IT systems and manage escalation processes. Develop and implement backup and restoration procedures for GMP systems. Conduct periodic reviews of GMP systems (user access, audit trails, performance). Maintain inventory and validation status of all systems. Support lifecycle activities such as URS development, risk assessments, vendor qualification, change control, and decommissioning. Collaborate with vendors on upgrades and service contracts to ensure continuous validation. Deliver training and create SOPs for end-users of validated systems. Minimum Requirements: Bachelors degree in Computer Science, Information Systems, Life Sciences, or a related technical field. 5+ years of experience with GMP computer systems and software validation. Strong working knowledge of FDA 21 CFR Part 11, GAMP 5, and CSV best practices. Technical expertise with system administration and lab instrumentation software. Strong documentation skills and experience with validation protocols and reports. Proficiency with system backup/recovery in regulated environments. Familiarity with Windows Server, Active Directory, and Group Policy. Preferred Qualifications: Experience supporting analytical lab instruments (HPLC, GC, etc.) and IT infrastructure. Knowledge of LIMS and other lab data management systems. Experience with virtualization platforms (VMware/Hyper-V), cybersecurity principles, and remote support tools. Background working in FDA-regulated (GxP) laboratory environments. 9840722