MES Solution Architect (Siemens Opcenter Pharma / Werum PAS-X)
Capgemini
Capgemini
Join Capgemini Engineering, a global leader in engineering and R&D, and drive digital manufacturing transformations for top Life Sciences organizations. This role focuses on MES, Smart Factory, and Industry 4.0 initiatives, empowering you to shape your career within a supportive, collaborative environment.
We are looking for a seasoned MES Solution Architect with deep expertise in Siemens Opcenter Pharma (Camstar) and/or Werum PAS-X. You will lead critical MES transformation programs for pharmaceutical, biotechnology, and life sciences clients, leveraging your strong understanding of manufacturing processes, system architecture, integration, and GxP compliance.
As an MES Solution Architect, you will spearhead MES solution design, implementation, and transformation projects using Siemens Opcenter Pharma (Camstar) and/or Werum PAS-X. This involves gathering and analyzing complex business and manufacturing requirements, translating them into robust, scalable MES architectures.
You will design and configure core MES functionalities, including Electronic Batch Records (EBR), Recipe Management, Weigh & Dispense, Genealogy, Traceability, and Production Execution. Crucially, you will define and implement integration strategies between MES and essential systems like ERP, LIMS, SCADA, Automation Systems, Serialization platforms, and Data Historians. Ensuring adherence to GMP, GAMP5, FDA 21 CFR Part 11, and other global regulatory requirements is paramount. Your responsibilities will also extend to leading architecture reviews, deployment planning, validation strategies, testing, and go-live activities.
This role requires a professional with 10 to 14 years of experience in MES, Manufacturing IT, Digital Manufacturing, or Smart Manufacturing environments. Hands-on expertise with Siemens Opcenter Pharma (Camstar) and/or Werum PAS-X is essential.
Ideal candidates possess a strong grasp of pharmaceutical, biotechnology, and life sciences manufacturing processes, with proven experience implementing MES solutions in regulated manufacturing settings. A solid understanding of integrating MES with ERP, LIMS, Automation Systems, SCADA, Serialization systems, and Data Historians is vital. Familiarity with ISA-95, Manufacturing Data Models, and Industry 4.0 concepts is expected.
While not mandatory, a Bachelor's or Master's degree in Engineering, Information Technology, Computer Science, Life Sciences, Biotechnology, or a related field is preferred. Experience leading global MES transformation programs for pharmaceutical or biotech companies is a significant advantage.
Capgemini
Pharmaceuticals