17.09.2026 aktualisiert
100 % verfügbar
Senior CSV / Automation / MES Consultant - Life Sciences & GxP
Lugano, Schweiz
Weltweit
MSc Robotics and Automation Engineering, University of Pisa, Italy (110/110 with honours)Über mich
Senior Validation Consultant (CSV/CSA) and IT Quality professional focused on Digital Technology eCompliance and Computer Systems Lifecycle Management in regulated GxP environments with 10+ years across pharma and biotech.
Skills
Azure DevOpsCloud-EngineeringPythonIT-Betriebsmanagement
Computer System Validation (CSV/CSA)
Full V-Model expertise covering URS, FS, DS, IQ, OQ, PQ and RTM under GAMP 5 (2nd Ed.). Bespoke software validation, paper-based, hybrid and paperless validation, as well as Agile and Waterfall delivery for regulated GxP environments in pharma, biotech and medical devices.
MES & Manufacturing Execution Systems
Hands-on experience with POMS POMSNet (cloud), Werum PAS-X and Emerson Syncade / DeltaV. Recipe authoring and qualification, batch manufacturing support for upstream and downstream pharma and biotech processes.
Data Integrity & GxP Compliance
Deep knowledge of 21 CFR Part 11, EU Annex 11, ALCOA+, PIC/S PI 041. Audit trail review, electronic records and electronic signatures, user access, backup/restore and data migration governance.
Cloud ERP Validation
Full validation of Microsoft Dynamics 365 Business Central for multi-site GMP rollouts. Legacy-to-cloud data migration governance and bespoke configuration validation under Waterfall and Agile methodologies.
Industrial Automation (IT/OT)
Validation and qualification of filling lines, DCS, PLC, HMI and SCADA systems. Supplier audits, FMEA and CSA including coverage of AI/ML and robotics technology.
Qualification of Emerging GxP Technologies
Qualification of AI/ML, computer vision and autonomous robotics under GAMP 5. Experience with smart inspection systems and medical-site automation.
Cybersecurity for GxP
NIST, SOC and ISO/IEC 27001 alignment for regulated IT/OT environments, including data integrity assessment under 21 CFR Part 11 and EU Annex 11.
DevOps & IT Infrastructure
Practical experience with Azure DevOps, Jira, Jenkins, Docker, Kubernetes, VMware and VirtualBox. Linux and Windows server environments, PostgreSQL and CI/CD pipelines.
Programming & Data Science
Proficiency in C, C++11, Python 3, Bash, MATLAB, SQL, Lua, JSON, HTML5, PHP and MySQL. Frameworks and libraries include PyTorch, NVIDIA CUDA, OpenCV, NumPy and SciPy.
AI / ML Algorithm Development
Design, validation and maintenance of AI/ML algorithms using NVIDIA CUDA, Linux servers and PyTorch for computer vision systems applied to medical imaging, inspection, robotics and IoT.
Full V-Model expertise covering URS, FS, DS, IQ, OQ, PQ and RTM under GAMP 5 (2nd Ed.). Bespoke software validation, paper-based, hybrid and paperless validation, as well as Agile and Waterfall delivery for regulated GxP environments in pharma, biotech and medical devices.
MES & Manufacturing Execution Systems
Hands-on experience with POMS POMSNet (cloud), Werum PAS-X and Emerson Syncade / DeltaV. Recipe authoring and qualification, batch manufacturing support for upstream and downstream pharma and biotech processes.
Data Integrity & GxP Compliance
Deep knowledge of 21 CFR Part 11, EU Annex 11, ALCOA+, PIC/S PI 041. Audit trail review, electronic records and electronic signatures, user access, backup/restore and data migration governance.
Cloud ERP Validation
Full validation of Microsoft Dynamics 365 Business Central for multi-site GMP rollouts. Legacy-to-cloud data migration governance and bespoke configuration validation under Waterfall and Agile methodologies.
Industrial Automation (IT/OT)
Validation and qualification of filling lines, DCS, PLC, HMI and SCADA systems. Supplier audits, FMEA and CSA including coverage of AI/ML and robotics technology.
Qualification of Emerging GxP Technologies
Qualification of AI/ML, computer vision and autonomous robotics under GAMP 5. Experience with smart inspection systems and medical-site automation.
Cybersecurity for GxP
NIST, SOC and ISO/IEC 27001 alignment for regulated IT/OT environments, including data integrity assessment under 21 CFR Part 11 and EU Annex 11.
DevOps & IT Infrastructure
Practical experience with Azure DevOps, Jira, Jenkins, Docker, Kubernetes, VMware and VirtualBox. Linux and Windows server environments, PostgreSQL and CI/CD pipelines.
Programming & Data Science
Proficiency in C, C++11, Python 3, Bash, MATLAB, SQL, Lua, JSON, HTML5, PHP and MySQL. Frameworks and libraries include PyTorch, NVIDIA CUDA, OpenCV, NumPy and SciPy.
AI / ML Algorithm Development
Design, validation and maintenance of AI/ML algorithms using NVIDIA CUDA, Linux servers and PyTorch for computer vision systems applied to medical imaging, inspection, robotics and IoT.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2022
Sprachen
DeutschGrundkenntnisseEnglischverhandlungssicherFranzösischGrundkenntnisseItalienischMuttersprache
Projekthistorie
Full validation of cloud-based ERP (Microsoft Dynamics 365 Business Central) for a multi-site GMP implementation. Full validation of cloud-based MES (POMS POMSNet) for a new-site implementation. Validation of filling-line update including supplier audits, FMEA and CSA covering AI/ML and robotics technology. Authored SOPs, work instructions, validation packages and templates; reviewed Change Requests, CAPAs and Deviations from a QA perspective. Cybersecurity and Data Integrity assessment under NIST, SOC, 21 CFR Part 11 and EU Annex 11.
Recipe authoring using Syncade MES and DeltaV in a controlled GMP environment. Upstream and downstream process support for pharma/biotech manufacturing.
CSV/CSA validation of IT/OT infrastructure supporting Werum PAS-X manufacturing environment. Tooling: MS Visio, Azure DevOps, ServiceNow, Kneat, MasterControl, TrackWise.