Senior Validation Lead, GxP Systems & LIMS

Southern Research; Chicago (IL); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical plan

Dental plan

Vision plan

401(k) match

Life insurance

Paid time off

Employee assistance program

Job summary

Southern Research is seeking a Senior Validation Analyst to lead validation initiatives across the lifecycle of GxP technologies. You will work with Business, IT, and Quality teams to define requirements and validate systems for use in regulated environments.

You will develop validation deliverables, manage testing activities, and ensure ongoing validated state through changes and periodic reviews while supporting audits and continuous improvement efforts.

Qualifications

• Bachelor’s degree in computer science or life sciences or related field
• 8+ years of experience in a Quality or Technical role with direct validation leadership
• Experience with LIMS and other GxP computerized systems in a lab environment
• Advanced knowledge of pharmaceutical/CRO regulations, standards and guidelines (GxP, CSV, 21 CFR Part 11, EU Annex 11)

Responsibilities

• Lead validation initiatives for new GxP technologies from assessment to retirement
• Develop validation deliverables: Validation Plan, User Requirements, Configuration Specification, Testing Strategy, Traceability, Validation Summary Reports
• Support validated state via change management and periodic reviews
• Investigate validation incidents and root causes; support production investigations
• Drive continuous improvement and retirement of obsolete technologies
• Communicate effectively with stakeholders and vendors; escalate as needed
• Prepare for and participate in audits; contribute to audit finding responses
• Lead cross-functional collaboration between Business, IT and Quality

Skills

Quality validation

GxP regulations

Project leadership

Risk management

Regulatory knowledge

Stakeholder communication

Analytical thinking

Change management

Education

Bachelor’s degree in life sciences or related field

Tools

LIMS

Chromatography Data Systems

Spectrophotometry Systems

Benchling

Veeva Quality

Provantis

SoftMax Pro

MSD Discovery Workbench

QuantStudio

Analyst

Job description

Southern Research is seeking a Senior Validation Analyst to lead validation initiatives across the lifecycle of GxP technologies. You will work with Business, IT, and Quality teams to define requirements and validate systems for use in regulated environments.

You will develop validation deliverables, manage testing activities, and ensure ongoing validated state through changes and periodic reviews while supporting audits and continuous improvement efforts.