Senior Software Validation Engineer

Medline Industries, LP

. Evaluate systems and applications to design organized and efficient software, process, automation, cleaning, facility, and utility system validations .

Posted 10/27/2026full-timeRemote • Illinois • United StatesSenior💰 $101,000 - $152,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GAMP 5 computerized system validations, project management, and regulatory compliance within the medical device industry. Proficient in designing and implementing risk-based test strategies while maintaining quality records and documentation.

Highest-signal resume keywords

GAMP 5 Computerized System ValidationFDA 21 CFR Part 820 ComplianceISO 13485 Quality Management SystemsProject ManagementManufacturing Quality Engineering

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk-Based Test StrategiesValidation ProtocolsSoftware ValidationDocument ControlQuality Records ManagementProcess AutomationValidation Project ManagementSoftware Engineering PracticesContinuous ImprovementKanban Methodology

Soft Skills

Customer CommunicationTeam SupportLeadershipInfluencing SkillsDetail Orientation

Tools & Technologies

MS WordMS ProjectMS ExcelAS400 Environment

Industry Keywords

FDA RegulationsISO StandardsMedical Device QMSQuality Management SystemsElectronic Records/SignaturesSoftware Validation PrinciplesRegulatory AuditsGS1/GUDID Management

About the role

Key responsibilities & impact

Evaluate systems and applications to design organized and efficient software, process, automation, cleaning, facility, and utility system validations
Design, develop, and implement risk-based test strategies, plans, scripts, and procedures
Manage multiple concurrent validation projects
Gather and understand customer requirements
Communicate project status to keep customers informed and satisfied
Document validation protocols and reports
Support Medline policies and relevant governing procedures
Maintain awareness of FDA, GAMP, ISO, and the broader industry and regulatory environment
Maintain document control, quality records, detail, and thoroughness
Evaluate and improve efficiencies in software validation and related processes
Provide team support for validation initiatives
Support division facilities on-site when needed

Requirements

What you’ll need

Bachelor’s degree in Engineering, Quality, Business, or Computer Science
At least 5 years of experience in Manufacturing, Quality or Engineering
At least 3 years of experience in GAMP 5 related computerized system validations, including designing, authoring, executing, and coordinating
Direct experience operating in a medical device QMS environment
Experience with FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principles of Software Validation, and Electronic Records/Signatures
Experience applying standard concepts, practices, and procedures within software engineering
Experience influencing, leading, and directing individuals in multiple functional areas
Experience with project management
Experience working in an AS400 environment
Ability to travel up to 25% of the time for business purposes, within state and out of state
Preferred: Experience in Manufacturing, Quality or Engineering including 4 major validation subjects
Preferred: Experience with QMS ISO 13485:2016, 21 CFR 820 QSR, 21 CFR Part 11, 21 CFR 801 Labeling, GAMP 5, ISO/customer/regulator audits, FDA product and establishment registration, GS1/GUDID management, and quality management systems
Preferred: Proficiency in MS Word, Project, and Excel
Preferred: Experience in people and process management
Preferred: Continuous improvement and Kanban project experience

Benefits

Comp & perks

Competitive total rewards package
Continuing education & training
Health insurance
Life and disability insurance
401(k) contributions
Paid time off
Employee Assistance Program
Employee Resource Groups
Employee Service Corp
Bonus and/or incentive eligibility
Career growth opportunities