Regulated Life Sciences Data & AI Engineer

Philogen S.p.A.

Milano

In loco

EUR 70.000 - 110.000

Tempo pieno

48 ore fa
Candidati tra i primi

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Descrizione del lavoro

Philogen S.p.A., Milano-based biotechnology company, seeks a Life Sciences Solutions Engineer to translate pharma data needs into robust data models and compliant AI/data systems for regulated workflows.

You will collaborate with engineering, clinical teams, quality, and legal to implement production-grade solutions, ensure privacy and security, and align with GxP and EU/US regulations while exploring responsible AI deployments.

Competenze

  • 5+ years of professional experience in software engineering, data engineering, solutions architecture, or a comparable hands-on technical role.
  • Deep professional expertise in pharmaceutical quality, regulated computerized systems, or clinical trials.
  • Strong coding skills, preferably in Python, with SQL and data-modeling experience.
  • Ability to understand complex data pipelines and trace how a source record is transformed, connected, and audited.
  • Ability to communicate effectively with software engineers and specialists from quality, clinical operations, data management, and compliance.
  • Experience in pharma/biotech/regulatory environments and English documentation.

Mansioni

  • Translate pharmaceutical and clinical requirements into implementable data models, workflows and access rules.
  • Guide software deployment through quality, privacy, security, and regulatory requirements.
  • Determine applicable regulatory frameworks for each use case.
  • Analyse clinical trial data across studies, sites, subjects, visits, forms, observations, queries, reviews, coding, and audit history.
  • Define and test controls for sensitive information, including role-based access and audit trails.
  • Produce and maintain validation plans, test evidence, and SOPs.

Conoscenze

Python
SQL
Data modeling
Communication
Regulatory knowledge
AI systems

Formazione

Master’s degree in Computer Science or Life Sciences

Strumenti

CDISC ODM
SDTM
ADaM
Kubernetes
RBAC
Infrastructure as Code

Descrizione del lavoro

Philogen S.p.A., Milano-based biotechnology company, seeks a Life Sciences Solutions Engineer to translate pharma data needs into robust data models and compliant AI/data systems for regulated workflows.

You will collaborate with engineering, clinical teams, quality, and legal to implement production-grade solutions, ensure privacy and security, and align with GxP and EU/US regulations while exploring responsible AI deployments.

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