Sr Engineer Software Validation

Medline • Redmond, OR

1d

About The Position

JOB SUMMARY Deliver leadership-level role in the development and execution of validation projects, ensuring customer and regulatory requirements are met in a timely and satisfactory manner. MAJOR RESPONSIBILITIES Evaluate systems and applications to properly design organized and efficient software, process, automation, cleaning, facility, and utility system related validations. Ensure scope and complexity of validations are commensurate with risk including the design, development, and implementation of test strategy, plans, scripts, and test procedures to meet requirements. Coordinate, Execute, and Report on validation plans for custom and off-the shelf software. Manage multiple, concurrent validation projects, including gathering and understanding customer requirements and effectively communicating project status to keep customer 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 to industry and regulatory environment, including FDA, GAMP, 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 development and upkeep of Divisional SOPs as related to software use. Provide system design feedback to ensure compliance with regulatory and Medline standards throughout the software development life cycle.

Requirements

• 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, 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 Principals of Software Validation, 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 (for example: planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives).

Nice To Haves

• Experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.).
• Experience with the following:
• - QMS – ISO13485:2016
• - 21 CFR 820 QSR, 21 CFR Part 11 Electronic Signature, 21 CFR 801 Labeling
• - GAMP Good Practice Guide: IT Infrastructure Control and Compliance (GAMP 5)
• - ISO / Customer / Regulator Audits
• - FDA Product and Establishment Registration
• - GS1 / GUDID Management
• - Quality Management System / Medical device environment experience.
• Proficient in MS Word, Project, Excel.
• Experience in people and process management.
• Continuous improvement and Kanban related project experience

Responsibilities

• Evaluate systems and applications to properly design organized and efficient software, process, automation, cleaning, facility, and utility system related validations.
• Ensure scope and complexity of validations are commensurate with risk including the design, development, and implementation of test strategy, plans, scripts, and test procedures to meet requirements.
• Coordinate, Execute, and Report on validation plans for custom and off-the shelf software.
• Manage multiple, concurrent validation projects, including gathering and understanding customer requirements and effectively communicating project status to keep customer 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 to industry and regulatory environment, including FDA, GAMP, 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 development and upkeep of Divisional SOPs as related to software use.
• Provide system design feedback to ensure compliance with regulatory and Medline standards throughout the software development life cycle.

Benefits

• Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
• Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees