Remote Senior Software Validation Lead

Medline; Illinois; A distancia; USD 101.000 - 152.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k) contributions

Paid time off

Descripción de la vacante

Medline is seeking a Sr Engineer Software Validation to lead and execute validation projects ensuring customer and regulatory requirements are met. You will design, develop, and implement validation strategies, plans, and test procedures while coordinating multiple projects and communicating progress to clients.

The role requires 5+ years in manufacturing/quality/engineering with 3+ years in GAMP 5, and experience with FDA QMS, ISO13485, and related standards.

Formación

• Bachelor’s degree in Engineering, Quality, Business, or Computer Science.
• 5+ years in Manufacturing, Quality, or Engineering; 3+ years in GAMP 5 computerized validation.
• Experience in FDA QMS environment and ISO13485, 21 CFR 11, and related regulations.

Responsabilidades

• Evaluate systems and applications for validation design and testing.
• Design and implement test strategies, plans, scripts, and procedures.
• Manage multiple validation projects and communicate status to customers.
• Document validation protocols and reports with professional writing.
• Support on-site validation for Medline facilities as needed.

Conocimientos

Software validation

Regulatory compliance

Project management

Leadership

Communication

GAMP 5

Educación

Bachelor's degree in Engineering, Quality, Business, or Computer Science

Herramientas

MS Word

MS Project

Excel

AS/400

Descripción del empleo

Medline is seeking a Sr Engineer Software Validation to lead and execute validation projects ensuring customer and regulatory requirements are met. You will design, develop, and implement validation strategies, plans, and test procedures while coordinating multiple projects and communicating progress to clients.

The role requires 5+ years in manufacturing/quality/engineering with 3+ years in GAMP 5, and experience with FDA QMS, ISO13485, and related standards.