Sr Engineer Software Validation

Overview

Lead the development and execution of software and process validation projects, ensuring customer and regulatory requirements are met in a timely and satisfactory manner.

What you'll do

• Evaluate systems and applications to design organized and efficient software, process, automation, cleaning, facility, and utility system validations.
• Ensure the scope and complexity of validations are commensurate with risk, including designing, developing, and implementing test strategy, plans, scripts, and test procedures to meet requirements.
• Manage multiple concurrent validation projects, gathering and understanding customer requirements and communicating project status to keep customers informed and satisfied.
• Document validation protocols and reports with professional and technical written communication skills.
• Know, support, and conform to Medline policies and relevant governing procedures.
• Maintain awareness of the industry and regulatory environment, including FDA, GAMP, and ISO.
• Maintain organizational excellence, including document control, quality records, detail, and thoroughness.
• Evaluate ways to streamline and improve efficiencies in software validation and associated processes.
• Provide team support in all validation initiatives as requested.
• Support division facilities on-site when needed.

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, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principles of Software Validation, and Electronic Records/Signatures.
• Experience applying knowledge of standard concepts, practices, and procedures within software engineering.
• Experience and skills in influencing, leading, and directing individuals in multiple functional areas.
• Experience with project management, such as planning, organizing, and managing resources to successfully complete specific project goals and objectives.
• Experience working in an AS400 environment.

Nice to have

• Experience in Manufacturing, Quality, or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.).
• Experience with QMS: ISO 13485:2016, 21 CFR 820 QSR, 21 CFR Part 11 Electronic Signature, 21 CFR 801 Labeling.
• Experience with GAMP Good Practice Guide: IT Infrastructure Control and Compliance (GAMP 5).
• Experience with ISO, customer, and regulator audits.
• Experience with FDA Product and Establishment Registration.
• Experience with GS1 / GUDID management.
• Quality Management System / medical device environment experience.
• Proficient in MS Word, Project, and Excel.
• Experience in people and process management.
• Continuous improvement and Kanban related project experience.

Details

• Remote position based in Illinois.
• Position requires travel up to 25% of the time for business purposes, within state and out of state.