Senior Validation Engineer - Quality Assurance (Hybrid)

Quva; Sugar Land (TX); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health benefits

401k with match

Paid time off

Overtime opportunities

Career advancement

Job summary

Quva is seeking a Senior Engineer, Corporate Quality Assurance — Validation to lead validation activities across equipment, processes, computerized systems, and analytical methods. You will drive risk-based validation lifecycles in a GMP environment and ensure regulatory alignment across sites.

The role emphasizes data integrity, cGMP compliance, and collaboration with IT, Operations, and Quality teams to enable project execution and ongoing operations with high precision.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related field.
• 5–8+ years in Quality Assurance, Validation, or related roles.
• Working knowledge of USP and ICH regulatory requirements.
• Familiarity with GMP environments.
• Experience reviewing and approving validation documentation.
• Strong background in laboratory validation.

Responsibilities

• Ensure analytical methods are validated and transferred in compliance with ICH, USP, and regulatory expectations.
• Oversee and enforce data integrity controls in line with FDA requirements and ALCOA+.
• Provide QA oversight of laboratory and validation activities to ensure compliance.
• Review and approve validation deliverables and lifecycle documents.
• Author and execute validation deliverables to support priorities.
• Serve as QA representative during audits and regulatory inspections.

Skills

Analytical validation

Data integrity

QA oversight

Validation documentation

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Advanced degree preferred

Tools

LIMS

Job description

Quva is seeking a Senior Engineer, Corporate Quality Assurance — Validation to lead validation activities across equipment, processes, computerized systems, and analytical methods. You will drive risk-based validation lifecycles in a GMP environment and ensure regulatory alignment across sites.

The role emphasizes data integrity, cGMP compliance, and collaboration with IT, Operations, and Quality teams to enable project execution and ongoing operations with high precision.