Hybrid Validation Specialist — CSA/GxP for SaaS

Experis Technology Group; Raleigh (NC); Hybrid; USD 75,000 - 107,000; Full time

Benefits offered by this job

Medical plan

Dental plan

Vision plan

HSA

FSA

Dependent care FSA

Life insurance

Disability insurance

Travel insurance

401(k) with match

Weekly pay

Job summary

Experis Technology Group in Raleigh, NC, seeks a Validation Specialist to implement and maintain GxP validation for R&D IT systems. You will apply GAMP 5 and CSA best practices, own the validation strategy, review processes, run meetings, and generate validation plans, URs, testing docs, and training materials.

You will support UAT and hypercare to keep systems validated. This hybrid role emphasizes collaboration across technical and regulatory teams, with a strong focus on SaaS validation,

Qualifications

• Recent CSA experience with strong understanding of US and EU regulations, including US CFR and EU Annex 11.
• Subject matter expertise in computer software assurance (CSA) and GxP computerized systems with practical GAMP 5 application.
• Ability to write validation deliverables and training documentation (e.g., User/Admin SOPs).
• Experience validating SaaS applications, with familiarity for electronic Instructions For Use and electronic Prescribing Information workflows.

Responsibilities

• Implement GxP computerized systems for R&D IT using GAMP 5 principles and CSA best practices.
• Own validation strategy and execution; review processes, lead meetings, align stakeholders on requirements and outcomes.
• Write and maintain validation plans, URs, testing documentation, change control support, and training materials.
• Support UAT and hypercare to maintain a validated state and assist regulatory readiness.

Skills

CSA experience

GxP regulatory knowledge

Stakeholder collaboration

Documentation writing

Job description

Experis Technology Group in Raleigh, NC, seeks a Validation Specialist to implement and maintain GxP validation for R&D IT systems. You will apply GAMP 5 and CSA best practices, own the validation strategy, review processes, run meetings, and generate validation plans, URs, testing docs, and training materials.

You will support UAT and hypercare to keep systems validated. This hybrid role emphasizes collaboration across technical and regulatory teams, with a strong focus on SaaS validation,