Senior Software Validation Engineer

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Assess systems and applications to create structured and effective software, process, automation, cleaning, facility, and utility system validations.

• Create, develop, and apply risk-based testing strategies, plans, scripts, and procedures.

• Oversee multiple simultaneous validation projects.

• Collect and comprehend customer requirements.

• Update customers on project status to ensure they are informed and satisfied.

• Record validation protocols and generate reports.

• Uphold Medline policies and relevant regulatory procedures.

• Stay informed about FDA, GAMP, ISO, and the broader industry and regulatory landscape.

• Ensure document control, quality records, detail, and thoroughness are maintained.

• Assess and enhance efficiencies in software validation and associated processes.

• Offer team support for validation initiatives.

• Provide on-site support for division facilities as needed.

⛳️ Requirements

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

• A minimum of 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 in a medical device Quality Management System (QMS) environment.

• Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principles of Software Validation, and Electronic Records/Signatures.

• Proficient in applying standard concepts, practices, and procedures in software engineering.

• Experience in influencing, leading, and guiding individuals across multiple functional areas.

• Background in project management.

• Experience working within an AS400 environment.

• Willingness to travel up to 25% of the time for business purposes, both in-state and out-of-state.

• Preferred: Experience in Manufacturing, Quality, or Engineering encompassing 4 major validation subjects.

• Preferred: Familiarity 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: Knowledge of continuous improvement and Kanban project methodologies.

🏝️ Benefits

• Competitive total rewards package.

• Continuing education and training opportunities.

• Health insurance.

• Life and disability insurance.

• 401(k) contributions.

• Paid time off.

• Employee Assistance Program.

• Employee Resource Groups.

• Employee Service Corp.

• Eligibility for bonuses and/or incentives.

• Opportunities for career growth.