MES Consultant with Camstar / Critical Manufacturing

Capgemini Engineering · Remote, India

We are looking for an experienced MES Consultant with expertise in Siemens Camstar and/or Critical Manufacturing MES to support digital manufacturing and smart factory initiatives within the Life Sciences industry

About the Role

The candidate should have strong experience in MES implementation, validation, integration, and manufacturing process optimization in regulated environments.

Responsibilities

• Lead MES implementation, enhancement, and support projects using Camstar and/or Critical Manufacturing.
• Gather business requirements and design MES solutions aligned with Life Sciences manufacturing processes.
• Configure MES functionalities including Electronic Batch Records (EBR), Weigh & Dispense, Genealogy, Traceability, Quality, and Production Execution.
• Integrate MES with ERP, LIMS, SCADA, Automation, and Serialization systems.
• Support system validation activities in compliance with GxP, FDA 21 CFR Part 11, and other regulatory requirements.
• Drive testing, deployment, go-live, and continuous improvement initiatives.
• Collaborate with manufacturing, quality, validation, and IT teams.

Qualifications

• 8–10 years of experience in MES/Manufacturing IT.
• Hands-on experience with Siemens Camstar and/or Critical Manufacturing MES.
• Strong understanding of Life Sciences manufacturing processes and regulatory requirements.
• Experience with MES integrations, SQL, APIs, and manufacturing data management.
• Familiarity with validation methodologies (CSV), GAMP5, FDA 21 CFR Part 11, and GMP environments.
• Knowledge of ISA-95 and Industry 4.0 concepts.

Required Skills

• 8–10 years of experience in MES/Manufacturing IT.
• Hands-on experience with Siemens Camstar and/or Critical Manufacturing MES.
• Strong understanding of Life Sciences manufacturing processes and regulatory requirements.
• Experience with MES integrations, SQL, APIs, and manufacturing data management.
• Familiarity with validation methodologies (CSV), GAMP5, FDA 21 CFR Part 11, and GMP environments.
• Knowledge of ISA-95 and Industry 4.0 concepts.

Preferred Skills

• Bachelor's degree in Engineering, IT, or related field.
• Experience in Pharmaceuticals, Biotechnology, or Medical Devices manufacturing.
• Strong communication, stakeholder management, and problem-solving skills.

Role Level: Senior Consultant / Lead Consultant

Technology: Siemens Camstar, Critical Manufacturing MES, EBR, Validation (CSV), GMP, GAMP5, Life Sciences Manufacturing.

Equal Opportunity Statement

We are committed to diversity and inclusivity in our hiring practices.