MES Consultant with Camstar / Critical Manufacturing

Capgemini Engineering; Pune District; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Capgemini Engineering in India seeks an experienced MES Consultant to support digital manufacturing initiatives in the Life Sciences sector. The role focuses on MES implementation, validation, integration, and process optimization in regulated environments.

You will lead projects using Siemens Camstar and/ or Critical Manufacturing MES, configure EBR, genealogy, traceability, quality, and production execution, and collaborate with IT, validation, and manufacturing teams to ensure compliant

Qualifications

• 8–10 years in MES/Manufacturing IT within Life Sciences.
• Hands-on Camstar and/or Critical Manufacturing MES experience.
• Knowledge of CSV validation, GAMP5, FDA 21 CFR Part 11 and GMP.

Responsibilities

• Lead MES implementation, enhancement, and support projects using Camstar and/or Critical Manufacturing.
• Gather requirements and design MES solutions for Life Sciences processes.
• Configure MES functions: EBR, Weigh & Dispense, Genealogy, Traceability, Quality, Production Execution.
• Integrate MES with ERP, LIMS, SCADA, Automation, Serialization.
• Support validation activities per GxP and FDA requirements.
• Drive testing, deployment, go-live, and continuous improvement.
• Collaborate with manufacturing, quality, validation, and IT teams.

Skills

MES/Manufacturing IT experience

Life Sciences regulatory knowledge

Experience with MES integrations

SQL & APIs experience

Education

Bachelor's degree in Engineering/IT

Tools

Siemens Camstar

Critical Manufacturing MES

SQL

APIs

Job description

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.

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.