Non Product Software Validation Engineer

Job Title

Job Description

Job Responsibilities:

• Develop, review and/or approve validation plans, protocols, scripts, and reports for computerized systems.

• Create and maintain validation documentation in accordance with established procedures and quality standards

• Verify that software systems meet user requirements, functional requirements, functional specifications, and intended use

• Participate in gathering and reviewing user and functional requirements

• Conduct Risk Assessments to determine validation scope and testing requirements

• Apply risk-based validation principles to ensure appropriate testing coverage

• Evaluate system changes and enhancements for validation impact

• Ensure compliance with applicable regulatory requirements, industry standards, and internal procedures

• Assist with CAPAs related to computerized systems

• Contribute to continuous improvement initiatives within the validation program

Minimum required Education:
Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.

Minimum required Experience:
Minimum 10-12 years of experience in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated industry.

Preferred Skills:
• Regulatory Requirements

• Quality Management Systems (QMS)
• Project Management
• Data Analysis & Interpretation
• Process Improvements
• Technical Writing
• Computer System Assurance Validation
• Agile Methodology
• Training Content Development
• Regulatory Compliance
• Business Acumen

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.