MES Solution Architect – Siemens Opcenter Pharma / Werum PAS-X

About the role

Capgemini Engineering is seeking a senior MES Solution Architect to lead digital manufacturing transformation programs for pharmaceutical, biotechnology and life‑science clients across India. You will design and implement MES solutions using Siemens Opcenter Pharma (Camstar) and/or Werum PAS-X, ensuring compliance with GxP regulations.

Key responsibilities

• Lead the design, configuration and deployment of MES solutions based on Siemens Opcenter Pharma and Werum PAS-X.
• Gather and translate business and manufacturing requirements into scalable MES architectures.
• Configure core MES functions such as Electronic Batch Records, Recipe Management, Weigh & Dispense, Genealogy, Traceability and Production Execution.
• Define integration strategies between MES and ERP, LIMS, SCADA, automation, serialization platforms and data historians.
• Ensure solutions meet GMP, GAMP5, FDA 21 CFR Part 11 and other global regulatory standards.
• Conduct architecture reviews, validation planning, testing and go‑live support.

Required profile

• 10–14 years of experience in MES, manufacturing IT or digital manufacturing within regulated environments.
• Hands‑on expertise with Siemens Opcenter Pharma (Camstar) and/or Werum PAS‑X.
• Strong knowledge of pharmaceutical, biotech and life‑science manufacturing processes.
• Proven experience delivering MES transformation programs for global life‑science organizations.

Required skills

• Siemens Opcenter Pharma (Camstar)
• Werum PAS‑X
• MES architecture and implementation
• GMP, GAMP5, FDA 21 CFR Part 11 compliance
• ISA‑95 manufacturing data models
• ERP, LIMS, SCADA and automation system integration
• Serialization platforms and data historians
• Electronic Batch Records, Recipe Management, Weigh & Dispense, Genealogy, Traceability, Production Execution
• Industry 4.0 concepts

What we offer

• Opportunity to work on large‑scale digital manufacturing projects for leading life‑science companies.
• Collaborative global community and continuous learning environment.
• Exposure to cutting‑edge Industry 4.0 technologies.