Senior Software Validation Engineer – Medical Devices

Regulatory Jobs; Illinois; On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a senior validation professional to lead development and execution of software and process validations ensuring compliance with FDA, ISO 13485, and GAMP 5 guidelines. You will manage multiple projects, craft validation strategies, and document protocols for quality systems and manufacturing environments.

The role requires 5+ years in manufacturing/quality/engineering with 3+ years in GAMP 5 computerized validations and experience in a medical device QMS.

Qualifications

• Bachelor's degree in Engineering, Quality, Business, or Computer Science.
• 5+ years of experience in Manufacturing, Quality or Engineering.
• 3+ years of experience in GAMP 5 related computerized system validations.
• Direct experience in a medical device QMS environment (FDA 21 CFR Part 820, ISO 13485, ISO 14971).
• Experience with software validation concepts, testing, and documentation.

Responsibilities

• Evaluate systems and applications to design validated software, process, automation, cleaning, facility, and utility validations.
• Design, develop, and implement test strategy, plans, scripts, and procedures to meet requirements.
• Manage multiple validation projects and communicate status to customers.
• Document validation protocols and reports with technical communication.
• Maintain awareness of FDA, GAMP, ISO regulations and industry standards.
• Improve efficiencies in software validation processes.
• Provide team support in validation initiatives and on-site facility support when needed.

Skills

Project management

Regulatory knowledge

Software validation

GAMP 5 familiarity

FDA 21 CFR Part 820 knowledge

AS400 experience

Willingness to travel

Education

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

Tools

AS400

MS Word

MS Project

MS Excel

Job description

Medline Industries, LP seeks a senior validation professional to lead development and execution of software and process validations ensuring compliance with FDA, ISO 13485, and GAMP 5 guidelines. You will manage multiple projects, craft validation strategies, and document protocols for quality systems and manufacturing environments.

The role requires 5+ years in manufacturing/quality/engineering with 3+ years in GAMP 5 computerized validations and experience in a medical device QMS.