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

Capgemini Engineering; Pune District; On-site; INR 2,800,000 - 5,200,000; Full time

Job summary

Capgemini Engineering seeks an experienced MES Solution Architect to lead MES transformation programs in Life Sciences. Focus on Siemens Opcenter Pharma (Camstar) and Werum PAS-X, translating requirements into scalable MES architectures and integrating with ERP/LIMS and shop-floor systems.

Ideal candidates have 8–10 years of MES experience, strong pharma manufacturing knowledge, and expertise in CSV and regulatory compliance, with leadership across cross-functional teams to drive digital

Qualifications

• 8–10 years 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 integrating MES with ERP, LIMS, and shop-floor systems.
• Knowledge of ISA-95, Manufacturing Data Models and Industry 4.0 concepts.
• Strong Computer System Validation (CSV) and regulatory compliance knowledge.

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 GMP, GAMP5, FDA 21 CFR Part 11 compliance.
• Lead solution architecture, validation strategy, deployment and go-live activities.
• Collaborate with Manufacturing, Quality, Validation and IT teams to drive digital manufacturing.
• Provide technical leadership, governance and mentoring to project teams.

Skills

MES experience

Opcenter Pharma Camstar

Werum PAS-X

Regulatory compliance

ISA-95

CSV (GxP)

Education

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

Tools

Siemens Opcenter Pharma (Camstar)

Werum PAS-X

Job description

Experience: 8-10 Years

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.