Life Sciences Solutions Engineer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7bytvk

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. /p h3Position Overview /h3 pWe are looking for a Life Sciences Solutions Engineer who combines strong coding skills with deep expertise in at least one of the following areas: /p ul liPharmaceutical quality systems or quality control. /li liGxP, computerized‑system compliance, or regulated software validation. /li liClinical trial operations, clinical data management, or trial oversight. /li /ul pThis 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. /p h3What You Will Do /h3 ul liTranslate pharmaceutical and clinical requirements into implementable data models, workflows and access rules. /li liGuide software deployment through the applicable quality, privacy, security, and regulatory requirements. /li liDetermine which regulatory frameworks apply to each use case rather than treating every healthcare system as subject to identical controls. /li liAnalyze clinical trial data covering studies, sites, subjects, visits, forms, observations, queries, reviews, medical coding, and audit history. /li liDefine and test controls for sensitive information, including role‑based access, separation of duties, approvals, and audit trails. /li liProduce and maintain documentation such as intended‑use definitions, risk assessments, traceability matrices, validation plans, test evidence, operating procedures, and change records. /li liWork with quality, clinical, security, legal, and engineering stakeholders to resolve differences between written procedures and actual system behavior. /li liSupport technical workshops, deployment planning, validation, training, and post‑deployment reviews. /li /ul h3What We Are Looking For /h3 ul li5+ years of professional experience in software engineering, data engineering, solutions architecture, technical consulting, or a comparable hands‑on technical role.



/li liDeep professional expertise in at least one of pharmaceutical quality, regulated computerized systems, or clinical trials. /li liStrong coding skills, preferably in Python, together with practical SQL and data‑modeling experience. /li liAbility to understand complex data pipelines and trace how a source record is transformed, connected, exposed, and audited. /li liAbility to communicate effectively with software engineers and specialists from quality, clinical operations, data management, and compliance. /li liExperience in a pharmaceutical, biotechnology, healthcare, CRO, technology consultancy, or regulated cloud/software environment. /li liStrong professional English and the ability to produce precise technical and validation documentation. /li liHigh daily engagement with modern AI tools and an interest in the responsible deployment of agent‑based systems. /li /ul h3Relevant Areas of Expertise /h3 pCandidates are not expected to know every framework below, but should have substantial practical experience in those relevant to their previous work: /p ul liICH Good Clinical Practice and clinical trial data governance. /li liGxP and pharmaceutical quality systems. /li liComputerized‑system validation and risk‑based Computer Software Assurance. /li liEU Annex 11 and FDA 21 CFR Part 11. /li liGDPR and health‑data access controls. /li liALCOA+ data‑integrity principles. /li liClinical data management, electronic data capture, source‑data review, clinical queries, coding, and trial audit trails. /li liEU medical‑device or software regulation where applicable to a system’s intended use. /li liQuality risk management, change control, deviation management, CAPA, and supplier qualification. /li /ul h3Nice to Have /h3 ul liExperience delivering infrastructure, data, or AI platforms for pharmaceutical customers. /li liFamiliarity with clinical data standards such as CDISC ODM, SDTM, or ADaM. /li liExperience with electronic data‑capture systems, clinical trial management systems,



quality‑management systems, laboratory systems, or regulatory document platforms. /li liKnowledge of cloud security, Kubernetes, identity management, RBAC, and infrastructure‑as‑code. /li liExperience with knowledge graphs, ontologies, AI agents, retrieval systems, or governed generative‑AI deployments. /li liExperience participating in audits, inspections, validation reviews, or regulated customer‑qualification processes. /li liA professional background as a software engineer, data engineer, or solutions architect before specializing in life sciences. /li /ul h3Education /h3 ul liMaster’s degree in Computer Science, Engineering, Data Science, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field. /li liA mixed technical and life‑sciences background is strongly preferred. /li liStrong academic credentials with international exposure. /li /ul h3What We Offer /h3 ul liCompetitive 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. /li liA hands‑on role at the intersection of software engineering, clinical operations, and pharmaceutical compliance. /li liThe opportunity to define how AI‑enabled systems are validated and introduced into regulated workflows. /li liDirect exposure to leadership and high‑impact projects across Philogen. /li liThe opportunity to contribute to applied AI across both operational and scientific workflows. /li liA fast‑moving, engineering‑driven environment focused on real delivery rather than prototypes. /li /ul h3Job Location /h3 pWe 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. /p pIn 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 #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7bytvk