i-Pharm GxP
Overview
Digital Manufacturing Systems SME is responsible for the design, configuration, and maintenance of electronic batch records and master recipes within the
Apprentice MES (Tempo) . This role ensures that production processes are accurately represented, compliant with cGMP regulations, and optimized for efficient execution on the manufacturing floor. The EBR Recipe Author collaborates cross-functionally with process engineering, manufacturing, quality assurance, and IT to translate paper-based or process documentation into compliant, user-friendly, and automated EBR workflows. Responsibilities
Create, configure, and validate electronic batch records and master recipes within the MES platform. Translate manufacturing process documentation (MBRs, SOPs, process flow diagrams) into compliant electronic workflows. Define equipment, materials, parameters, and process instructions within EBR templates. Collaborate with process engineers, quality, and IT to ensure recipes align with manufacturing and quality system requirements. Integrate MES workflows with ERP, LIMS, and automation systems as needed. Maintain consistency and standardization of recipe design across products and facilities. Experience
10+ years experience authoring or configuring Electronic Batch Records (EBR) in a pharmaceutical, biotech, or regulated manufacturing environment. Hands-on experience with Apprentice (required) or other MES platforms (e.g., Werum PAS-X, Emerson Syncade, Rockwell PharmaSuite). Strong understanding of GMP and data integrity principles. Familiarity with manufacturing processes for biologics, vaccines, or sterile drug products. Proficiency in MES configuration, recipe design, and workflow logic. Understanding of integration with ERP, automation, and quality systems. Strong analytical and problem-solving skills; attention to detail in documentation and validation activities. Seniority level
Mid-Senior level Employment type
Contract Job function
Manufacturing Industries
Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
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Digital Manufacturing Systems SME is responsible for the design, configuration, and maintenance of electronic batch records and master recipes within the
Apprentice MES (Tempo) . This role ensures that production processes are accurately represented, compliant with cGMP regulations, and optimized for efficient execution on the manufacturing floor. The EBR Recipe Author collaborates cross-functionally with process engineering, manufacturing, quality assurance, and IT to translate paper-based or process documentation into compliant, user-friendly, and automated EBR workflows. Responsibilities
Create, configure, and validate electronic batch records and master recipes within the MES platform. Translate manufacturing process documentation (MBRs, SOPs, process flow diagrams) into compliant electronic workflows. Define equipment, materials, parameters, and process instructions within EBR templates. Collaborate with process engineers, quality, and IT to ensure recipes align with manufacturing and quality system requirements. Integrate MES workflows with ERP, LIMS, and automation systems as needed. Maintain consistency and standardization of recipe design across products and facilities. Experience
10+ years experience authoring or configuring Electronic Batch Records (EBR) in a pharmaceutical, biotech, or regulated manufacturing environment. Hands-on experience with Apprentice (required) or other MES platforms (e.g., Werum PAS-X, Emerson Syncade, Rockwell PharmaSuite). Strong understanding of GMP and data integrity principles. Familiarity with manufacturing processes for biologics, vaccines, or sterile drug products. Proficiency in MES configuration, recipe design, and workflow logic. Understanding of integration with ERP, automation, and quality systems. Strong analytical and problem-solving skills; attention to detail in documentation and validation activities. Seniority level
Mid-Senior level Employment type
Contract Job function
Manufacturing Industries
Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
#J-18808-Ljbffr