Solution Architect ( Werum PAS-X)

MES Solution Architect (Siemens Opcenter Pharma / Werum PAS-X)

Experience: 8–10 Years

Location - PAN India

Role Summary

We are seeking an experienced MES Solution Architect with expertise in Siemens Opcenter Pharma (Camstar) and/or Werum PAS-X to lead MES transformation programs within Life Sciences organizations.

• Lead MES solution design and implementation using Siemens Opcenter Pharma and/or Werum PAS-X.
• Translate business and manufacturing requirements into scalable MES architectures.
• Design and configure solutions for Electronic Batch Records (EBR), Recipe Management, Weigh & Dispense, Genealogy, Traceability, and Production Execution.
• Integrate MES with ERP, LIMS, Automation/SCADA, Serialization, and Data Historians.
• Ensure compliance with GMP, GAMP5, FDA 21 CFR Part 11, and global regulatory requirements.
• Lead solution architecture, validation strategy, deployment, and go-live activities.
• Collaborate with Manufacturing, Quality, Validation, and IT teams to drive digital manufacturing initiatives.
• Provide technical leadership, governance, and mentoring to project teams.

Required Skills

• 8–10 years of experience in MES, Manufacturing IT, or Digital Manufacturing.
• Hands-on experience with Siemens Opcenter Pharma (Camstar) and/or Werum PAS-X.
• Strong understanding of pharmaceutical and biotech manufacturing processes.
• Experience in MES integrations with ERP, LIMS, and shop-floor systems.
• Knowledge of ISA-95, Manufacturing Data Models, and Industry 4.0 concepts.
• Strong understanding of Computer System Validation (CSV) and regulatory compliance.

Preferred Qualifications

Bachelor's/Master's degree in Engineering, Life Sciences, or Information Technology.

Experience working with global pharmaceutical or biotechnology companies.

Knowledge of cloud, analytics, and smart manufacturing platforms.

Strong stakeholder management, communication, and consulting skills.

What will you love working at Capgemini

• The company emphasizes team spirit, trust, and innovation, creating a positive and inclusive work environment. Employees often mention a sense of appreciation and purpose in their roles
• Capgemini scores 3.7/5 for work-life balance, with many developers appreciating the flexible work hours and hybrid work model