Senior Software Validation Lead - Medical Devices

Medline Industries, LP; United States; Remote; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k)

Paid time off

Job summary

Medline Industries, LP is seeking a senior validation professional to lead the development and execution of validation projects in a regulated environment. You will ensure alignment with FDA/ISO/GAMP requirements and meet customer expectations through careful planning and documentation.

The role requires at least 5 years in manufacturing/quality/engineering and hands-on experience with GAMP 5 computerized validations, AS/400 operations, and cross-functional leadership.

Qualifications

• Bachelor’s degree in Engineering, Quality, Business, or Computer Science.
• At least 5 years in Manufacturing, Quality or Engineering.
• At least 3 years in GAMP 5 related computerized system validations.
• Experience in a medical device QMS environment with FDA/ISO references.

Responsibilities

• Evaluate systems and applications to properly design validations for software, processes, cleaning, and facilities.
• Design, develop, 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.
• Maintain awareness of FDA/ISO/GAMP regulations and internal policies.
• Improve efficiencies in validation processes and provide team support on-site as needed.

Skills

Project management

Leadership

Kanban

Continuous improvement

Software engineering concepts

Education

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

Tools

MS Word

Project

Excel

AS/400

Job description

Medline Industries, LP is seeking a senior validation professional to lead the development and execution of validation projects in a regulated environment. You will ensure alignment with FDA/ISO/GAMP requirements and meet customer expectations through careful planning and documentation.

The role requires at least 5 years in manufacturing/quality/engineering and hands-on experience with GAMP 5 computerized validations, AS/400 operations, and cross-functional leadership.