Senior CSV & Validation Lead - Regulated Systems Expert

OnShore Technology Group; Chicago (IL); On-site; USD 120,000 - 170,000; Full time

Job summary

OnShore Technology Group in Chicago, IL, seeks a Sr. Validation Lead to oversee CSV activities for designated computerized system implementations in GMP/GLP/GCP environments.

You will develop and review validation test protocols, coordinate with SMEs, and ensure all deliverables align with FDA 21 CFR Part 11, ISPE GAMP 5, and related regulations. The ideal candidate has 10+ years in software quality assurance within life sciences, strong leadership, and proven ability to manage multiple CSV

Qualifications

• Education: B.S. or equivalent in computer science, engineering, life sciences, or related field.
• ASQ CSQE Certification or equivalent preferred.

Responsibilities

• Lead and coordinate multiple CSV projects.
• Develop / review validation test protocols using automated tools.
• Coordinate with SMEs and other departments.
• Ensure validation deliverables comply with internal guidelines and procedures.
• Create and track validation project plans.
• Provide regulatory guidance on CSV principles to the team.

Education

B.S. or equivalent in computer science, engineering, life sciences, or related field

ASQ CSQE Certification or equivalent preferred

Job description

OnShore Technology Group in Chicago, IL, seeks a Sr. Validation Lead to oversee CSV activities for designated computerized system implementations in GMP/GLP/GCP environments.

You will develop and review validation test protocols, coordinate with SMEs, and ensure all deliverables align with FDA 21 CFR Part 11, ISPE GAMP 5, and related regulations. The ideal candidate has 10+ years in software quality assurance within life sciences, strong leadership, and proven ability to manage multiple CSV