Job Title
Non-Product Software Validation Engineer
Job Description
Non-Product Software Validation Engineer
As an NPSS QA Manager, you will own and strengthen the validation and assurance framework for non-product software and computerized systems used in a regulated medical device environment. You will partner with process owners, IT, Quality, Regulatory, Cybersecurity, Privacy, suppliers, and project teams to ensure systems are fit for intended use, compliant, inspection-ready, and maintained in a validated state.
Your role:
- Provide quality oversight and consultancy across the full computerized system lifecycle, including intended use, classification, validation planning, requirements, risk assessment, supplier assessment, test strategy, traceability, release, change control, periodic review, incident and problem management, and retirement.
- Develop, implement, and maintain computerized system validation deliverables, procedures, and guidance for CSV and Computer Software Assurance (CSA).
- Collaborate effectively with project teams and the NPSS team, consistently applying current GxP standards.
- Apply a risk-based, critical-thinking approach that scales assurance activities to patient safety, product quality, data integrity, regulatory, and business risk.
- Author, review, and approve validation and assurance deliverables, including validation plans, requirements and specifications, risk assessments, protocols or test evidence, traceability documentation, deviations, reports, and validation summaries.
- Ensure electronic records, electronic signatures, audit trails, access controls, data migration, interfaces, backup and restore, and data integrity controls are appropriately assessed and verified where applicable.
- Advise projects using Agile, DevOps, cloud, SaaS, configurable platforms, ERP, QMS, manufacturing, analytics, and other enterprise applications on compliant lifecycle controls and objective evidence.
- Assess and leverage supplier documentation and automated testing evidence where justified through documented risk and quality decisions.
- Ensure validated systems remain in a controlled state through change impact assessments, periodic reviews, issue and CAPA management, and lifecycle monitoring.
- Prepare for and support internal audits, external audits, and regulatory inspections. Present validation strategies and evidence and coordinate clear, timely responses to observations.
- Lead cross-functional resolution of complex quality and compliance issues, facilitate risk-based decisions, and escalate significant compliance risks when needed.
- Drive measurable improvements in validation efficiency, right-first-time quality, standardization, automation, and inspection readiness without weakening compliance controls.
- Coach and mentor validation engineers, validation leads, system owners, testers, and project team members, and develop or deliver role-based training on lifecycle and assurance requirements.
You're the right fit if:
- Bachelor’s or master’s degree in engineering, computer science, information systems, life sciences, quality, or a related technical field, or equivalent relevant experience.
- At least 8 years of relevant experience in computerized systems, software quality, validation, quality assurance, or quality systems within medical devices, pharmaceutical, biotechnology, diagnostics, or another highly regulated life sciences industry.
- Demonstrable hands-on experience planning, authoring, executing, reviewing, and approving CSV or CSA deliverables for complex computerized systems.
- Strong working knowledge of risk-based validation, data integrity, electronic records and signatures, configuration and change control, supplier assurance, and maintaining systems in a validated state.
- Experience supporting audits or inspections and explaining and defending validation strategies, risk decisions, and objective evidence to auditors or regulators.
- Ability to translate regulatory and quality requirements into practical controls for business, IT, and project teams.
- Excellent technical writing, facilitation, stakeholder management, and verbal communication skills in English.
- Ability to influence without direct authority, manage competing priorities, and make well-reasoned quality decisions in a matrix organization.
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.
About Philips
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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.