Lead CSV Specialist – Compliance & System Validation

Ushitecsolutions; Dallas (TX); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading technology solutions provider located in Dallas, TX, is searching for a Computer System Validation Specialist. In this role, you will manage the validation of laboratory systems to ensure compliance with regulatory standards. Your responsibilities include leading validation projects, developing protocols, and conducting risk assessments. The ideal candidate will have a Bachelor's degree in a scientific or engineering discipline and a minimum of 4 years of relevant experience.

Qualifications

• Minimum 4+ years of experience in Computer Systems Validation.
• Strong understanding of GAMP 5 and FDA requirements.
• Proven ability to prepare and execute IQ/OQ/PQ protocols.

Responsibilities

• Oversee validation of laboratory systems to ensure compliance.
• Develop and execute validation protocols.
• Conduct risk assessments to mitigate validation risks.

Skills

Computer Systems Validation (CSV)

GAMP 5

FDA data integrity

Risk assessment (FMEA)

Collaboration with Quality Operations

Analytical skills

Education

Bachelor’s degree in a scientific or engineering discipline

Tools

Empower3

LabX

Job description

A leading technology solutions provider located in Dallas, TX, is searching for a Computer System Validation Specialist. In this role, you will manage the validation of laboratory systems to ensure compliance with regulatory standards. Your responsibilities include leading validation projects, developing protocols, and conducting risk assessments. The ideal candidate will have a Bachelor's degree in a scientific or engineering discipline and a minimum of 4 years of relevant experience.