/n 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 /n /n About the Role /n The candidate should have robust experience in MES implementation, validation, integration, and manufacturing process optimization in regulated environments. /n Responsibilities /n /n

- Lead MES implementation, enhancement, and support projects using Camstar and/or Critical Manufacturing.

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- Gather business requirements and design MES solutions aligned with Life Sciences manufacturing processes.

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- Configure MES functionalities including Electronic Batch Records (EBR), Weigh & Dispense, Genealogy, Traceability, Quality, and Production Execution.

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- Integrate MES with ERP, LIMS, SCADA, Automation, and Serialization systems.

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- Support system validation activities in compliance with GxP, FDA 21 CFR Part 11, and other regulatory requirements.

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- Drive testing, deployment, go-live, and continuous improvement initiatives.

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- Collaborate with manufacturing, quality, validation, and IT teams.

/n /n /n Qualifications /n /n

- 8–10 years of experience in MES/Manufacturing IT.

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- Hands-on experience with Siemens Camstar and/or Critical Manufacturing MES.

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- Strong understanding of Life Sciences manufacturing processes and regulatory requirements.

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- Experience with MES integrations, SQL, APIs, and manufacturing data management.

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- Familiarity with validation methodologies (CSV), GAMP5, FDA 21 CFR Part 11, and GMP environments.

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- Knowledge of ISA-95 and Industry 4.0 concepts.

/n /n /n Required Skills /n /n

- 8–10 years of experience in MES/Manufacturing IT.

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- Hands-on experience with Siemens Camstar and/or Critical Manufacturing MES.

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- Strong understanding of Life Sciences manufacturing processes and regulatory requirements.

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- Experience with MES integrations, SQL, APIs, and manufacturing data management.

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- Familiarity with validation methodologies (CSV), GAMP5, FDA 21 CFR Part 11, and GMP environments.

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- Knowledge of ISA-95 and Industry 4.0 concepts.

/n /n /n Preferred Skills /n /n

- Bachelor's degree in Engineering, IT, or related field.

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- Experience in Pharmaceuticals, Biotechnology, or Medical Devices manufacturing.

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- Strong communication, stakeholder management, and problem-solving skills.

/n /n /n Role Level: Senior Consultant / Lead Consultant /n /n Technology: Siemens Camstar, Critical Manufacturing MES, EBR, Validation (CSV), GMP, GAMP5, Life Sciences Manufacturing. /n /n Equal Opportunity Statement /n We are committed to diversity and inclusivity in our hiring practices. /n

📌 MES Consultant with Camstar / Critical Manufacturing (Pune)
🏢 Capgemini Engineering
📍 Pune