Solution Architect ( Werum PAS-X)

Capgemini Engineering; Bengaluru; Remote; INR 4,000,000 - 6,500,000; Full time

Benefits offered by this job

Hybrid approach

Global life sciences exposure

Job summary

Capgemini Engineering is seeking an experienced MES Solution Architect to lead MES transformation programs in life sciences. You will design and implement MES using Siemens Opcenter Pharma (Camstar) and/or Werum PAS-X, translating complex manufacturing requirements into scalable architectures.

You will drive integration with ERP, LIMS, SCADA and data historians, ensure GMP and 21 CFR Part 11 compliance, and oversee validation, deployment, and go-live activities while mentoring teams.

Qualifications

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

Responsibilities

• Lead MES solution design and implementation using Siemens Opcenter Pharma and/or Werum PAS-X.
• Translate requirements into scalable MES architectures and configurations.
• Design and configure EBR, Recipe Management, Weigh & Dispense, and Traceability.
• Integrate MES with ERP, LIMS, Automation/SCADA, Serialization, and Data Historians.
• Lead validation strategy, governance, deployment, and go-live activities.
• Collaborate with Manufacturing, Quality, Validation and IT teams; mentor project teams.

Skills

MES

Manufacturing IT

Digital manufacturing

GAMP5

CSV compliance

Regulatory knowledge

ISA-95

System integration

Education

Bachelor's/Master's in Engineering/Life Sciences/IT

Tools

Siemens Opcenter Pharma (Camstar)

Werum PAS-X

Job description

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