MES Solution Architect - Pharma/Biotech Domain

Job Title:

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.