About the team
Our Enterprise Delivery practice brings together software engineering, systems integration, program governance, and specialist advisors to support enterprise modernization.
About the role
You will advise an ERP program manager and customer quality stakeholders on risk-based computerized systems validation (CSV) for prospective ERP implementations in regulated industries. The work centers on defined reviews, project milestones, and periodic meetings. The customer retains responsibility for regulated quality decisions and final validation approvals.
In this role, you will:
- Review validation strategies and identify ERP functions with quality or regulatory implications.
- Assess requirements traceability, test coverage, and validation evidence.
- Review validation plans, test protocols, deviation records, and summary reports.
- Coordinate validation dependencies with the implementation and quality teams.
- Advise during CRP, UAT, cutover readiness, and production release.
- Identify documentation gaps and data integrity risks, recommend corrective actions, and escalate unresolved issues.
- Participate in readiness reviews and summarize validation status for program leadership.
You might thrive in this role if you:
- Have 5+ years in computerized systems validation or regulated enterprise software.
- Have validated ERP, manufacturing, quality, laboratory, or comparable enterprise applications.
- Understand applicable FDA requirements, including 21 CFR Part 11 where applicable.
- Have practical experience with GAMP 5, GxP, data integrity, and risk-based testing.
- Can evaluate user requirements, traceability matrices, test evidence, deviations, and validation reports.
- Can communicate risks clearly to IT, Quality Assurance, Manufacturing, and implementation partners while working a limited weekly schedule.
Experience in FDA-regulated manufacturing is preferred. QAD validation experience is valuable; experience validating comparable enterprise platforms is welcome.
About USATII
USATII is an enterprise software engineering company headquartered in Rochester, New York. We design, build, and integrate operational software for organizations with complex workflows. USATII is an equal opportunity employer.
Compensation
The proposed rate is $60–$75 per hour, with 3–6 hours per week anticipated during ordinary advisory periods. Hours may increase temporarily during testing, validation reviews, or go-live preparation by mutual agreement.
The contract depends on customer award, approved funding, mutually agreed terms, and whether the final scope requires independent validation advice. Submitting an expression of interest does not guarantee an engagement or minimum hours.
Applying
Submit your résumé and describe the systems you helped validate, the industries and frameworks you worked with, and a validation deliverable or readiness review you personally owned. Include your weekly availability, rate expectations, and interest in future fractional engagements.