04/24/2026 updated
FA
100 % available
Process & Automation Engineer | PAS-X MES | GxP | ABB 800xA | Pharmaceutical Manufacturing
uppsala, Sweden
Germany +8
MSc in Chemical Engineering - Specialization: Pharmaceuticalsinfo: Germany, Switzerland, United Kingdom, Denmark, Finland, Ireland, Netherlands, Norway, Sweden
ABB 800xaGXP
PAS-X MES & MES-DCS Integration
Certified PAS-X MES knowledge covering Master Data management, MBR structure, BOM, Equipment Master configuration, EBR workflow definition, and MES-DCS integration via OPC-UA (IEC 62541). Direct involvement in integration design sessions and MES configuration validation at a large-scale greenfield biologics facility.
DCS Automation & ABB 800xA
Hands-on FAT/SAT lead experience with the ABB 800xA DCS system, including HMI testing, FDS authoring, OPC-UA parameter push architecture, and AC 800M controller. Co-development of Functional Design Specifications with automation teams across multiple countries.
GxP / GMP & Computer System Validation
Strong knowledge of GxP-regulated pharmaceutical and advanced manufacturing environments, including 21 CFR Part 11, EU Annex 11, GAMP 5, IQ/OQ/PQ lifecycle, and Computer System Validation (CSV). Formal training and practical application in protocol review and SOP development.
Batch Control (ISA-88 / IEC 61512)
Knowledge of ISA-88 and IEC 61512 physical and procedural models, recipe hierarchy design, SFC/ST phase logic, and OPC-UA interface design for batch control systems in pharmaceutical manufacturing.
Process Engineering & Technology Transfer
Development and review of PFDs, P&IDs, URS, and equipment data sheets for technology transfer. Experience with CIP method development, FMEA, HAZOP, Dust Hazard Analysis, and scale-up activities in GMP environments.
Pharma / Biotech & Analytical Methods
Experience in MAb production including chromatography resin manufacturing, QC lab management, and analytical techniques such as GC-MS, LC-MS, and FTIR in GMP pharmaceutical environments.
Documentation & Quality Systems
Authoring and reviewing SOPs, URS, FDS, IQ/OQ/PQ protocols, deviation reports, and change control documentation in compliance with GMP and regulatory standards.
Process Simulation & Engineering Tools
Practical use of COMSOL Multiphysics for process simulation, ibaAnalyzer for process monitoring, AutoCAD Plant 3D for plant design, Minitab for statistical analysis, and Navisworks for 3D model review.
Project & Cross-functional Team Leadership
Cross-functional team leadership, vendor management, FAT/SAT coordination, and operator training delivery across international teams in Sweden and the USA. Sub-project management experience including material and consumable qualification projects.
Certified PAS-X MES knowledge covering Master Data management, MBR structure, BOM, Equipment Master configuration, EBR workflow definition, and MES-DCS integration via OPC-UA (IEC 62541). Direct involvement in integration design sessions and MES configuration validation at a large-scale greenfield biologics facility.
DCS Automation & ABB 800xA
Hands-on FAT/SAT lead experience with the ABB 800xA DCS system, including HMI testing, FDS authoring, OPC-UA parameter push architecture, and AC 800M controller. Co-development of Functional Design Specifications with automation teams across multiple countries.
GxP / GMP & Computer System Validation
Strong knowledge of GxP-regulated pharmaceutical and advanced manufacturing environments, including 21 CFR Part 11, EU Annex 11, GAMP 5, IQ/OQ/PQ lifecycle, and Computer System Validation (CSV). Formal training and practical application in protocol review and SOP development.
Batch Control (ISA-88 / IEC 61512)
Knowledge of ISA-88 and IEC 61512 physical and procedural models, recipe hierarchy design, SFC/ST phase logic, and OPC-UA interface design for batch control systems in pharmaceutical manufacturing.
Process Engineering & Technology Transfer
Development and review of PFDs, P&IDs, URS, and equipment data sheets for technology transfer. Experience with CIP method development, FMEA, HAZOP, Dust Hazard Analysis, and scale-up activities in GMP environments.
Pharma / Biotech & Analytical Methods
Experience in MAb production including chromatography resin manufacturing, QC lab management, and analytical techniques such as GC-MS, LC-MS, and FTIR in GMP pharmaceutical environments.
Documentation & Quality Systems
Authoring and reviewing SOPs, URS, FDS, IQ/OQ/PQ protocols, deviation reports, and change control documentation in compliance with GMP and regulatory standards.
Process Simulation & Engineering Tools
Practical use of COMSOL Multiphysics for process simulation, ibaAnalyzer for process monitoring, AutoCAD Plant 3D for plant design, Minitab for statistical analysis, and Navisworks for 3D model review.
Project & Cross-functional Team Leadership
Cross-functional team leadership, vendor management, FAT/SAT coordination, and operator training delivery across international teams in Sweden and the USA. Sub-project management experience including material and consumable qualification projects.
Languages
EnglishFluent
Project history
Independent subject-matter expert providing AI training and advisory work with a focus on process engineering. Contributes chemical and process engineering domain expertise to improve AI reasoning and is engaged to support industrial clients on process engineering challenges.
Dual-role process and automation engineer on a large-scale greenfield manufacturing facility in the US. Key contributions include MES-DCS integration design sessions, PAS-X Master Data scoping, EBR workflow definition, FAT lead for ABB 800xA DCS, FDS co-development, FMEA and HAZOP sessions, CIP method development, IQ/OQ/PQ protocol review, and technology transfer documentation including PFDs, P&IDs, and URS.
Established and led a QC laboratory from scratch including equipment setup, process design, and operator qualification. Optimized epoxy curing processes using COMSOL Multiphysics simulations. Diagnosed process deviations using ibaAnalyzer. Led chemical safety projects and managed material qualification projects as sub-project manager. Acted as technical interface between R&D and production during scale-up of new bushing products.