Senior Software Validation Engineer — Regulatory & QA Leader

Medline Industries, LP; Springfield (IL); On-site; USD 101,000 - 152,000; Full time

Job summary

Medline Industries, LP is seeking a senior Validation Lead to drive the development and execution of validation projects ensuring compliance with customer and regulatory requirements.

You will evaluate systems and applications to design robust validation strategies, manage multiple projects, and document protocols and reports. On-site work in Illinois will require collaboration across departments and facilities while navigating FDA and ISO guidelines.

Qualifications

• Bachelor’s degree in Engineering, Quality, Business, or Computer Science.
• 5+ years in Manufacturing, Quality or Engineering; 3+ years in GAMP 5 validated computer systems.
• Experience in a medical device QMS environment, including FDA 21 CFR Part 820, ISO 13485, ISO 14971.

Responsibilities

• Evaluate systems to design validation for software, processes, automation, cleaning, facility, and utilities.
• Design, develop, and implement test strategy, plans, scripts, and procedures to meet requirements.
• Manage multiple validation projects and communicate status to keep customers informed.
• Document validation protocols and reports with professional written communication.
• Support Medline policies and relevant governing procedures.
• Maintain awareness of FDA, GAMP, ISO regulatory environment.
• Maintain organizational excellence through documentation and quality records.
• Identify ways to streamline and improve validation processes.
• Provide team support in all validation initiatives as requested.
• Support division facilities on-site when needed.

Skills

Project management

Software engineering concepts

Leadership

AS400 experience

Travel up to 25%

Education

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

Tools

MS Word

MS Project

MS Excel

AS400

Job description

Medline Industries, LP is seeking a senior Validation Lead to drive the development and execution of validation projects ensuring compliance with customer and regulatory requirements.

You will evaluate systems and applications to design robust validation strategies, manage multiple projects, and document protocols and reports. On-site work in Illinois will require collaboration across departments and facilities while navigating FDA and ISO guidelines.