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

Capgemini Engineering; Mumbai; Remote; INR 350,000 - 520,000; Full time

Job summary

Capgemini Engineering is seeking an experienced MES Solution Architect (Siemens Opcenter Pharma/Camstar and Werum PAS-X) to lead MES transformation programs for pharmaceutical and life sciences clients. Location PAN India, 10-14 years in MES and Manufacturing IT.

You will design architectures, gather requirements, define integration with ERP/LIMS/SCADA, and ensure GMP/GAMP5 compliance, validation strategies, and go-live activities.

Qualifications

• 10-14 years of MES, Manufacturing IT, or Smart Manufacturing experience.
• Hands-on with Siemens Opcenter Pharma (Camstar) and/or Werum PAS-X.
• Experience in regulated GMP/GAMP5 environments.

Responsibilities

• Lead MES solution design, implementation, and transformation initiatives using Siemens Opcenter Pharma (Camstar) and/or Werum PAS-X.
• Gather and analyze business and manufacturing requirements and translate them into scalable MES architectures.
• Design and configure MES functionalities including Electronic Batch Records, Recipe Management, Weigh & Dispense, Genealogy, Traceability, and Production Execution.
• Define architecture and integration strategies between MES and ERP, LIMS, SCADA, Automation Systems, Serialization platforms, and Data Historians.
• Ensure solutions comply with GMP, GAMP5, FDA 21 CFR Part 11, and global regulatory requirements.
• Lead solution architecture reviews, deployment planning, validation strategies, testing, and go-live activities.

Skills

MES Architecture

System Integration

Regulatory Compliance

GxP Environments

ISA-95

Education

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

Tools

Siemens Opcenter Pharma (Camstar)

Werum PAS-X

ERP

LIMS

SCADA

Automation Systems

Serialization

Job description

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

Location: PAN India

Experience: 10-14 Years

Choosing Capgemini means choosing a company where you'll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what's possible. Join us in helping leading Life Sciences organizations accelerate their digital manufacturing transformation through MES, Smart Factory, and Industry 4.0 initiatives.

Role Overview

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 for pharmaceutical, biotechnology, and life sciences clients.

The ideal candidate will possess strong knowledge of pharmaceutical manufacturing processes, MES architecture, system integration, regulatory compliance, and digital manufacturing solutions within GxP-regulated environments.

Key Responsibilities

• Lead MES solution design, implementation, and transformation initiatives using Siemens Opcenter Pharma (Camstar) and/or Werum PAS-X.
• Gather and analyze business and manufacturing requirements and translate them into scalable MES architectures.
• Design and configure MES functionalities including Electronic Batch Records (EBR), Recipe Management, Weigh & Dispense, Genealogy, Traceability, and Production Execution.
• Define architecture and integration strategies between MES and ERP, LIMS, SCADA, Automation Systems, Serialization platforms, and Data Historians.
• Ensure solutions comply with GMP, GAMP5, FDA 21 CFR Part 11, and global regulatory requirements.
• Lead solution architecture reviews, deployment planning, validation strategies, testing, and go-live activities.

Ideal Candidate Profile

• 10-14 years of experience in MES, Manufacturing IT, Digital Manufacturing, or Smart Manufacturing environments.
• Hands-on experience with Siemens Opcenter Pharma (Camstar) and/or Werum PAS-X.
• Strong understanding of pharmaceutical, biotechnology, and life sciences manufacturing processes.
• Experience implementing MES solutions in regulated manufacturing environments.
• Experience integrating MES with ERP, LIMS, Automation Systems, SCADA, Serialization systems, and Data Historians.
• Strong knowledge of ISA-95, Manufacturing Data Models, and Industry 4.0 concepts.

Preferred Qualifications

• Bachelor's or Master's degree in Engineering, Information Technology, Computer Science, Life Sciences, Biotechnology, or a related discipline.
• Experience delivering MES transformation programs for global pharmaceutical, biotech, or life sciences companies.

What You'll Love About Working Here

You'll work on large-scale digital manufacturing and MES transformation programs for leading pharmaceutical, biotechnology, and life sciences organizations.

About Us

At Capgemini Engineering, the global leader in engineering and R&D services, we bring together engineers, scientists, and technology experts to help the world's most innovative companies unlock their potential