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

Capgemini Engineering; Bengaluru; On-site; INR 3,000,000 - 5,500,000; Full time

Job summary

Capgemini Engineering is seeking an experienced MES Solution Architect to lead SAP-compatible MES transformations within Life Sciences. You will guide architecture, design, and deployment for EBR, Recipe Management, and production execution while ensuring GMP, GAMP5, and FDA 21 CFR Part 11 compliance across global sites.

You will collaborate with Manufacturing, Quality, Validation, and IT teams to drive digital manufacturing initiatives and mentor project teams.

Qualifications

• 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.

Responsibilities

• 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 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.

Skills

Stakeholder management

Communication skills

Consulting skills

Regulatory compliance understanding

GxP principles

Education

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

Tools

Siemens Opcenter Pharma (Camstar)

Werum PAS-X

ERP

LIMS

Automation/SCADA

Job description

Job Description Industry: Life Sciences / Pharmaceuticals / Biotechnology

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. The ideal candidate will have strong knowledge of pharmaceutical manufacturing processes, MES architecture, system integration, and regulatory compliance in GxP environments.

Key Responsibilities

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.

Technology: Siemens Opcenter Pharma, Werum PAS-X, MES, EBR, CSV, GMP, GAMP5, Industry 4.0, Life Sciences Manufacturing.