Senior Validation Engineer – QA & Regulatory Compliance

RXinsider LTD.; Sugar Land (TX); Hybrid; USD 110,000 - 170,000; Full time

Benefits offered by this job

Health benefits

401k plan

Paid time off

Job summary

Quva is seeking a Senior Engineer, Corporate Quality Assurance – Validation to drive validated systems and lifecycle documentation in a US FDA-regulated environment. You will validate analytical methods, equipment, processes, and computerized systems, ensuring data integrity and regulatory compliance across sites.

This hybrid role, based in Sugar Land, Texas, partners with IT, QC, Validation, and Manufacturing to deliver scientifically sound, compliant validation deliverables and support audits,

Qualifications

• Experience with analytical validation and data integrity in GMP/GLP environments.
• Familiarity with USP/ICH regulatory expectations and Part 11.
• Ability to author/review validation documentation and risk assessments.

Responsibilities

• Validate analytical methods, equipment, processes, and computerized systems.
• Ensure data integrity and compliance across validation activities.
• Oversee IQ/OQ/PQ/PV protocols and change controls; support audits.
• Collaborate with QC, Validation, IT, Manufacturing; ensure lifecycle compliance.
• Investigate validation deviations and data integrity issues; drive CAPA.
• Mentor junior staff and cross-functional teams in validation best practices.

Skills

Analytical validation

Data integrity

Regulatory compliance

QA oversight

Audits & inspections

Cross-functional collaboration

Technical leadership

Education

Bachelor's degree in Engineering/Life Sciences/Chemistry

Tools

LIMS

Job description

Quva is seeking a Senior Engineer, Corporate Quality Assurance – Validation to drive validated systems and lifecycle documentation in a US FDA-regulated environment. You will validate analytical methods, equipment, processes, and computerized systems, ensuring data integrity and regulatory compliance across sites.

This hybrid role, based in Sugar Land, Texas, partners with IT, QC, Validation, and Manufacturing to deliver scientifically sound, compliant validation deliverables and support audits,