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

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About the Role

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

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Responsibilities

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- 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.
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Qualifications

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- 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.
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Required Skills

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- 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.
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Preferred Skills

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- 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.
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Role Level: Senior Consultant / Lead Consultant

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

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Equal Chance Statement

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

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