LIFE SCIENCES SOLUTIONS ENGINEER
Philogen
Pharmaceutical Industry
20148 Milano, Lombardia - Italien
Senior Specialist / Project Manager
Experteer Overview
In this role you bridge software engineering and regulated life sciences to deploy AI and data systems in validated workflows. You’ll work closely with engineers, clinical teams, quality, and compliance to translate pharma/clinical requirements into data models and compliant deployments. The role involves inspecting data, defining controls, and producing solid validation documentation, with a focus on scalable, production-grade solutions. You will influence how AI-enabled systems are introduced into regulated operations, delivering impact across clinical and quality domains.
Compensation / Benefits
- Full-time employment under CCNL
- Competitive gross annual salary (70,000–110,000 EUR)
- Hands-on role at intersection of software, clinical operations, and compliance
- Opportunities to define AI-system validation in regulated workflows
- Exposure to leadership and high-impact projects
- Engineering-driven, fast-moving environment
Responsibilities
- Translate pharmaceutical and clinical requirements into data models, workflows and access rules
- Guide software deployment respecting quality, privacy, security, and regulatory requirements
- Identify applicable regulatory frameworks for each use case
- Analyze clinical trial data across studies, sites, subjects, forms, queries, and audit history
- Define and test controls for sensitive information, including RBAC, separation of duties, approvals, and audit trails
- Produce and maintain validation and operational documentation (risk assessments, traceability, test evidence)
- Collaborate with quality, clinical, security, legal, and engineering to align procedures with system behavior
- Support workshops, deployment planning, validation, training, and post-deployment reviews
Key requirements
- 5+ years in software engineering, data engineering, solutions architecture, or a similar technical role
- Deep expertise in pharmaceutical quality, regulated computerized systems, or clinical trials
- Strong coding skills in Python and practical SQL and data-modeling experience
- Ability to trace data pipelines from source to transformed and audited state
- Effective communication with engineers and cross-functional stakeholders
- Experience in pharma/biotech/healthcare/regulatory environment
- Proficient in English and in producing precise technical/validation documentation
- Experience with modern AI tools and responsible deployment of agent-based systems
Description
In this role you bridge software engineering and regulated life sciences to deploy AI and data systems in validated workflows. You’ll work c…
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