Sr Engineer Software Validation

Location: Redmond, Oregon, United States

Salary: $101,000–$152,000 annual, plus bonus and/or incentive eligibility.

Company

hirify.global is a growing worldwide medical device organization providing regulated products and systems.

What you will do

• Lead the development and execution of software, process, automation, cleaning, facility, and utility system validation projects.
• Design risk-based validation strategies, plans, scripts, test procedures, and reports.
• Coordinate and execute validation plans for custom and off-the-shelf software.
• Manage multiple concurrent projects, gather customer requirements, and communicate project status.
• Maintain validation protocols, quality records, document control, and divisional SOPs.
• Provide system design feedback and improve validation efficiency 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 designing, authoring, executing, and coordinating GAMP 5 computerized system validations.
• Direct experience in a medical device QMS environment, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, software validation principles, and electronic records/signatures.
• Experience applying software engineering concepts and managing projects, resources, and objectives.
• Experience influencing, leading, and directing people across multiple functional areas.

Nice to have

• Experience across major validation subjects such as computer, equipment, cleaning, and process validation.
• Knowledge of 21 CFR Part 11, 21 CFR Part 801, GAMP 5, regulatory audits, FDA registrations, GS1, and GUDID management.
• Proficiency in Microsoft Word, Project, and Excel.
• People and process management experience.
• Continuous improvement and Kanban project experience.

Culture & Benefits

• Competitive total rewards package.
• Continuing education and training opportunities.
• Health insurance, life and disability insurance, 401(k) contributions, and paid time off for eligible employees.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for employees working fewer than 30 hours per week.
• Inclusive workplace focused on belonging, diversity, and career growth.