MES Consultant (Camstar / Critical Manufacturing) - Medical Devices

MES Consultant (Camstar / Critical Manufacturing) – Medical Devices

Location: India
Experience: 10–18 Years

Choosing Capgemini means joining a global team that is transforming manufacturing through digital innovation, smart factory solutions, and Industry 4.0 technologies. We help Life Sciences and Medical Devices organizations improve operational excellence, compliance, quality, and manufacturing performance.

Role Overview

We are seeking an experienced MES Consultant with expertise in Siemens Camstar and/or Critical Manufacturing MES to support MES implementation, integration, validation, and optimization initiatives within regulated Life Sciences and Medical Devices environments. The role involves collaborating with business and technology stakeholders to design and deliver compliant, scalable manufacturing solutions.

Key Responsibilities

• Lead MES implementation, enhancement, and support projects using Siemens Camstar and/or Critical Manufacturing.
• Gather business requirements and translate them into MES functional and technical solutions.
• Configure and implement MES capabilities including Electronic Batch Records (EBR), Weigh & Dispense, Genealogy, Traceability, Quality Management, and Production Execution.
• Integrate MES with ERP, LIMS, SCADA, automation platforms, and serialization systems.
• Support Computer System Validation (CSV) activities in compliance with GxP, GMP, FDA 21 CFR Part 11, and GAMP5 guidelines.
• Drive testing, deployment, go-live support, and continuous improvement initiatives.
• Collaborate with manufacturing, quality, validation, engineering, and IT teams to ensure successful project delivery.
• Contribute to smart factory and Industry 4.0 transformation programs.

Ideal Candidate Profile

• 10–18years of experience in MES, Manufacturing IT, or Digital Manufacturing environments.
• Hands-on experience with Siemens Camstar and/or Critical Manufacturing MES platforms.
• Strong understanding of Life Sciences, Pharmaceutical, Biotechnology, or Medical Devices manufacturing processes.
• Experience with MES integrations, SQL, APIs, and manufacturing data management.
• Knowledge of ISA-95 standards, manufacturing execution processes, and Industry 4.0 concepts.
• Strong analytical, stakeholder management, communication, and problem-solving skills.

Preferred Qualifications

• Bachelor’s degree in Engineering, Information Technology, or a related discipline.
• Experience working in regulated GMP environments.
• Familiarity with validation methodologies, compliance frameworks, and quality-driven manufacturing operations.

Technology & Domain

Siemens Camstar | Critical Manufacturing MES | EBR | CSV | GAMP5 | GMP | FDA 21 CFR Part 11 | ISA-95 | Manufacturing Integration | Life Sciences | Medical Devices