Senior Validation Lead – GxP Systems

Southern Research; Alabama; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Match

Life Insurance

PTO

Employee Assistance Program

Job summary

Southern Research seeks a Senior Validation Analyst to lead strategic validation initiatives for new GxP technologies from assessment through retirement. You will author validation deliverables and ensure systems remain validated, collaborating with Business, IT, and Quality teams to define standard processes and requirements and to demonstrate fit for use.

The role requires deep regulatory knowledge (GxP, 21 CFR Part 11, EU Annex 11) and the ability to manage multiple validation projects

Qualifications

• Bachelor’s degree in computer science or life sciences, or equivalent experience.
• 8+ years in a Quality or IT/Technical role with direct experience leading validation efforts.
• Experience with LIMS and other computerized systems in a GxP laboratory environment (e.g., Chromatography Data Systems, Spectrophotometry).
• Advanced knowledge of pharmaceutical/CRO regulations (GxP, CSV, 21 CFR Part 11, EU Annex 11).

Responsibilities

• Lead system validation efforts, including strategy, risk management, and project management.
• Develop and maintain validation deliverables (Validation Plan, URS, Configuration Spec, Test Scripts, VSRs).
• Support lifecycle maintenance, change management, and periodic review of validated systems.

Skills

Validation leadership

Regulatory knowledge

Project management

Education

Bachelor’s degree in computer science or life sciences

8+ years in Quality/Technical role

Tools

LIMS

Chromatography Data Systems

Spectrophotometry Systems

Benchling

Job description

Southern Research seeks a Senior Validation Analyst to lead strategic validation initiatives for new GxP technologies from assessment through retirement. You will author validation deliverables and ensure systems remain validated, collaborating with Business, IT, and Quality teams to define standard processes and requirements and to demonstrate fit for use.

The role requires deep regulatory knowledge (GxP, 21 CFR Part 11, EU Annex 11) and the ability to manage multiple validation projects