p About Philogen p Philogen S.p.A. is a biotechnology company dedicated to developing targeted products for the imaging and treatment of life-threatening diseases, with a strategic focus on oncology. Our mission is to translate cutting-edge scientific innovation into effective therapies that improve patients' lives. /pp Position Overview /pp We are looking for a Life Sciences Solutions Engineer who combines strong coding skills with deep expertise in at least one of the following areas: /pulli Pharmaceutical quality systems or quality control. /lili GxP, computerized-system compliance, or regulated software validation. /lili Clinical trial operations, clinical data management, or trial oversight. /li /ulp This is not a documentation-only compliance role. You will inspect data, write code, configure and test systems, and work directly with engineers, clinical teams, quality specialists, and business stakeholders. You will guide the introduction of production-grade AI and data systems into regulated workflows. /pp What You Will Do /pulli Translate pharmaceutical and clinical requirements into implementable data models, workflows and access rules. /lili Guide software deployment through the applicable quality, privacy, security, and regulatory requirements. /lili Determine which regulatory frameworks apply to each use case rather than treating every healthcare system as subject to identical controls. /lili Analyze clinical trial data covering studies, sites, subjects, visits, forms, observations, queries, reviews, medical coding, and audit history. /lili Define and test controls for sensitive information, including role-based access, separation of duties, approvals, and audit trails. /lili Produce and maintain documentation such as intended-use definitions, risk assessments, traceability matrices, validation plans, test evidence, operating procedures, and change records. /lili Work with quality, clinical, security, legal, and engineering stakeholders to resolve differences between written procedures and actual system behavior. /lili Support technical workshops, deployment planning, validation, training, and post-deployment reviews. /li /ulp What We Are Looking For /pulli5+ years of professional experience in software engineering, data engineering, solutions architecture, technical consulting, or a comparable hands-on technical role.



/lili Deep professional expertise in at least one of pharmaceutical quality, regulated computerized systems, or clinical trials. /lili Strong coding skills, preferably in Python, together with practical SQL and data-modeling experience. /lili Ability to understand complex data pipelines and trace how a source record is transformed, connected, exposed, and audited. /lili Ability to communicate effectively with software engineers and specialists from quality, clinical operations, data management, and compliance. /lili Experience in a pharmaceutical, biotechnology, healthcare, CRO, technology consultancy, or regulated cloud/software environment. /lili Strong professional English and the ability to produce precise technical and validation documentation. /lili High daily engagement with modern AI tools and an interest in the responsible deployment of agent-based systems. /li /ulp Relevant Areas of Expertise /pp Candidates are not expected to know every framework below, but should have substantial practical experience in those relevant to their previous work: /pulli ICH Good Clinical Practice and clinical trial data governance. /lili GxP and pharmaceutical quality systems. /lili Computerized-system validation and risk-based Computer Software Assurance. /lili EU Annex 11 and FDA 21 CFR Part 11. /lili GDPR and health-data access controls. /lili ALCOA+ data-integrity principles. /lili Clinical data management, electronic data capture, source-data review, clinical queries, coding, and trial audit trails. /lili EU medical-device or software regulation where applicable to a system's intended use. /lili Quality risk management, change control, deviation management, CAPA, and supplier qualification. /li /ulp Nice to Have /pulli Experience delivering infrastructure, data, or AI platforms for pharmaceutical customers. /lili Familiarity with clinical data standards such as CDISC ODM, SDTM, or ADaM. /lili Experience with electronic data-capture systems, clinical trial management systems, quality-management systems, laboratory systems, or regulatory document platforms.



/lili Knowledge of cloud security, Kubernetes, identity management, RBAC, and infrastructure-as-code. /lili Experience with knowledge graphs, ontologies, AI agents, retrieval systems, or governed generative-AI deployments. /lili Experience participating in audits, inspections, validation reviews, or regulated customer-qualification processes. /lili A professional background as a software engineer, data engineer, or solutions architect before specializing in life sciences. /li /ulp Education /pulli Master's degree in Computer Science, Engineering, Data Science, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field. /lili A mixed technical and life-sciences background is strongly preferred. /lili Strong academic credentials with international exposure. /li /ulp What We Offer /pulli Full-time employment under the Chemical and Pharmaceutical Industry CCNL. /lili Competitive gross annual salary ranging from €70,000 to €110,000 RAL. Positioning within the salary range will be determined based on objective and neutral criteria, taking into account the candidate's skills, experience, and the level of responsibility associated with the role, as assessed throughout the selection process. /lili A hands-on role at the intersection of software engineering, clinical operations, and pharmaceutical compliance. /lili The opportunity to define how AI-enabled systems are validated and introduced into regulated workflows. /lili Direct exposure to leadership and high-impact projects across Philogen. /lili The opportunity to contribute to applied AI across both operational and scientific workflows. /lili A fast-moving, engineering-driven environment focused on real delivery rather than prototypes. /li /ulp Job Location /pp Milan, Italy. /pp We invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief. /pp In compliance with Directive (EU) 2023/970 and Italian Legislative Decree No. 96 of 7 May 2026, this job advertisement has been drafted using gender-neutral criteria. /p /p

📌 Life Sciences Solutions Engineer (Lombardia)
🏢 Philogen
📍 Lombardia