Senior Software Validation Engineer

🔥 0 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $101k - $152k / year

⏰ Full Time

🟠 Senior

👷🏻‍♀️ Engineer

👻 Ghost score 0%

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Medline Industries, LP

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1910

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 Private Equity Round on 2021-06

Healthcare • Logistics • Manufacturing

Medline Industries, LP is a leading healthcare company that focuses on improving clinical, financial, and operational outcomes for its customers. The company offers a wide array of over 335,000 medical products and boasts extensive warehousing capabilities with more than 28 million square feet of space. With a significant global presence of 43,000 employees, Medline provides agile and scalable solutions across all points of care, achieving a 95% next-day delivery rate within the US. The company's mission is to enhance healthcare delivery by providing superior products, supply chain resilience, and clinical expertise, all while fostering strong customer relationships through tailored, problem-solving solutions.

📋 Description

• 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

• 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

• 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