MES Consultant with Camstar / Critical Manufacturing

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. 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.