pstrongAbout Philogen /strong /ppPhilogen 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. /ppbr / /ppstrongPosition Overview /strong /ppWe are looking for a Life Sciences Solutions Engineer who combines strong coding skills with deep expertise in at least one of the following areas: /pulliPharmaceutical quality systems or quality control. /liliGxP, computerized-system compliance, or regulated software validation. /liliClinical trial operations, clinical data management, or trial oversight. /li /ulpbr / /ppThis 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. /ppbr / /ppstrongWhat You Will Do /strong /pulliTranslate pharmaceutical and clinical requirements into implementable data models, workflows and access rules. /liliGuide software deployment through the applicable quality, privacy, security, and regulatory requirements. /liliDetermine which regulatory frameworks apply to each use case rather than treating every healthcare system as subject to identical controls. /liliAnalyze clinical trial data covering studies, sites, subjects, visits, forms, observations, queries, reviews, medical coding, and audit history. /liliDefine and test controls for sensitive information, including role-based access, separation of duties, approvals, and audit trails. /liliProduce and maintain documentation such as intended-use definitions, risk assessments, traceability matrices, validation plans, test evidence, operating procedures, and change records. /liliWork with quality, clinical, security, legal, and engineering stakeholders to resolve differences between written procedures and actual system behavior. /liliSupport technical workshops, deployment planning, validation, training, and post-deployment reviews. /li /ulpbr / /ppstrongWhat We Are Looking For /strong /pulli5+ years of professional experience in software engineering, data engineering, solutions architecture, technical consulting, or a comparable hands-on technical role.



/liliDeep professional expertise in at least one of pharmaceutical quality, regulated computerized systems, or clinical trials. /liliStrong coding skills, preferably in Python, together with practical SQL and data-modeling experience. /liliAbility to understand complex data pipelines and trace how a source record is transformed, connected, exposed, and audited. /liliAbility to communicate effectively with software engineers and specialists from quality, clinical operations, data management, and compliance. /liliExperience in a pharmaceutical, biotechnology, healthcare, CRO, technology consultancy, or regulated cloud/software environment. /liliStrong professional English and the ability to produce precise technical and validation documentation. /liliHigh daily engagement with modern AI tools and an interest in the responsible deployment of agent-based systems. /li /ulpbr / /ppstrongRelevant Areas of Expertise /strong /ppCandidates are not expected to know every framework below, but should have substantial practical experience in those relevant to their previous work: /ppbr / /pulliICH Good Clinical Practice and clinical trial data governance. /liliGxP and pharmaceutical quality systems. /liliComputerized-system validation and risk-based Computer Software Assurance. /liliEU Annex 11 and FDA 21 CFR Part 11. /liliGDPR and health-data access controls. /liliALCOA+ data-integrity principles. /liliClinical data management, electronic data capture, source-data review, clinical queries, coding, and trial audit trails. /liliEU medical-device or software regulation where applicable to a system’s intended use. /liliQuality risk management, change control, deviation management, CAPA, and supplier qualification. /li /ulpbr / /ppstrongNice to Have /strong /pulliExperience delivering infrastructure, data, or AI platforms for pharmaceutical customers. /liliFamiliarity with clinical data standards such as CDISC ODM, SDTM, or ADaM. /liliExperience with electronic data-capture systems, clinical trial management systems, quality-management systems, laboratory systems, or regulatory document platforms.



/liliKnowledge of cloud security, Kubernetes, identity management, RBAC, and infrastructure-as-code. /liliExperience with knowledge graphs, ontologies, AI agents, retrieval systems, or governed generative-AI deployments. /liliExperience participating in audits, inspections, validation reviews, or regulated customer-qualification processes. /liliA professional background as a software engineer, data engineer, or solutions architect before specializing in life sciences. /li /ulpbr / /ppstrongEducation /strong /pulliMaster’s degree in Computer Science, Engineering, Data Science, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field. /liliA mixed technical and life-sciences background is strongly preferred. /liliStrong academic credentials with international exposure. /li /ulpbr / /ppstrongWhat We Offer /strong /pulliFull-time employment under the Chemical and Pharmaceutical Industry CCNL. /liliCompetitive 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. /liliA hands-on role at the intersection of software engineering, clinical operations, and pharmaceutical compliance. /liliThe opportunity to define how AI-enabled systems are validated and introduced into regulated workflows. /liliDirect exposure to leadership and high-impact projects across Philogen. /liliThe opportunity to contribute to applied AI across both operational and scientific workflows. /liliA fast-moving, engineering-driven environment focused on real delivery rather than prototypes. /li /ulpbr / /ppstrongJob Location /strong /ppMilan, Italy. /ppbr / /ppemWe 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. /em /ppbr / /ppemIn 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. /em /p

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