UST · 1 month ago
GxP Validation Analyst
Kentucky
Full-time
Onsite
Mid, Senior Level
$68K/yr - $102K/yr
6+ years expUST is a mission-driven company that transforms lives through technology. They are seeking an experienced GxP Validation Analyst to support a global instrument software validation initiative, focusing on documenting and validating software in compliance with EMA guidelines and collaborating with cross-functional teams for regulatory compliance.
ConsultingInformation ServicesInformation Technology
Responsibilities
Gather and document user requirements (URS) and software configurations
Develop and execute validation protocols (IQ, OQ, PQ as applicable)
Prepare requirement specifications, infrastructure diagrams, and data flow documentation
Perform risk assessments and maintain traceability from requirements → risks → tests → results
Support migration and alignment of instrument software management with IT SOPs
Ensure compliance with EMA guidelines and GAMP principles
Communicate effectively with laboratory, IT, QA, and vendor teams throughout the project lifecycle
Qualification
Required
Bachelor's degree in Life Sciences, Computer Science, or Engineering
6–9 years of relevant validation experience (pharma, biotech, or CRO preferred)
Strong technical writing and documentation skills
Proven experience in software validation for lab instruments or GxP systems
In-depth knowledge of EMA guidelines, Annex 11, and GAMP 4
Ability to create infrastructure and data flow diagrams
Detail-oriented with excellent communication and stakeholder engagement skills
Preferred
Familiarity with CSA (Computer Software Assurance) principles is a plus
Benefits
10 days of paid vacation per year
6 days of paid sick leave each year
10 paid holidays
Paid bereavement leave
Jury duty
401(k) Retirement Plan with employer matching
Medical, dental, and vision insurance
Basic life insurance
Accidental death and disability insurance
Short- and long-term disability benefits
Voluntary short-term disability benefits
Health Savings Account (HSA)
Flexible Spending Account (FSA)
Company
UST
UST is a Digital Transformations Solutions Provider.
10001+ employees
H1B Sponsorship
UST has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (870)
2024 (800)
2023 (647)
2022 (634)
2021 (612)
2020 (984)
Funding
Current Stage
Late StageTotal Funding
$250MKey Investors
Temasek Holdings
2018-06-27Private Equity· $250M
Leadership Team
Krishna Sudheendra
CEO
Alexander Varghese
Chief Administrative Officer & COO
Recent News
2026-01-05
Techcircle
2025-12-31
Hindu Business Line
2025-12-18
Company data provided by crunchbase