Jobs via Dice
Title: MES Technical Consultant
Regulatory Relevance: GxP
The Role The MES Technical Consultant will serve a key role owning the development and validation of core MES recipe objects and accompanying integrations. Additionally, this individual will also be well‑versed in Infobatch report development, web development, SQL, and ISA S‑95 standards. He/She will act as an escalation point contact for the MES, Infobatch, and ODH teams for complex initiatives.
Key Responsibilities
Lead the design, development, and implementation of MES core objects (custom behaviors, execution groups, etc.) using the Syncade platform.
Lead the design, development, and implementation of custom batch reports using the Infobatch platform.
Own the development and validation of complex web parts/application (ability to build custom tools using C# and web application using Node JS / Next JS, React).
Own the development and validation of complex labeling solutions (Crystal reports, Infobatch reports).
Provide technical leadership and guidance to junior engineers and project teams.
Deep understanding of Syncade database schema and adept at authoring SQL queries for ad‑hoc data needs.
Install, configure and maintain Manufacturing Execution Systems utilizing industry best practices.
Participate in the technical transfer of new products and processes from Tech Dev into Manufacturing.
Identify opportunities to improve existing processes, equipment, systems, and infrastructure by utilizing industry best practices.
Directly support operations with troubleshooting and issue resolution with respect to computer and automation systems.
Participate in validation activities with IT, Manufacturing, and QA related to implementation and ongoing support.
Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
Execute tasks precisely as defined in internal guiding documents including SOPs and work instructions.
Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
Ensure compliance with regulatory requirements and industry standards.
Stay up‑to‑date with emerging trends and technologies in MES engineering.
Troubleshoot and resolve technical issues related to MES systems and processes.
Required Background
Education: A bachelor’s degree in Engineering, Computer Science, or other technical degree.
Experience: Minimum 7+ years authoring and/or executing MES electronic batch records in the pharmaceutical or biotech industries.
Deep understanding of Syncade database schema and ability to author complex queries for ad‑hoc data needs.
Web development skills: Node JS, Next JS, React, Node‑RED, Flow Fuse.
Database skills: SQL, GraphQL.
Demonstrated aptitude or ability to learn GxP regulations, understanding of Good Automated Manufacturing Practices (GAMP) and Computer System Validation (CSV).
Experience designing recipes based on ISA 95 and ISA 88 standards and best practices.
Experience with software development and programming languages such as C#, Java, or SQL.
Strong knowledge of MES concepts, including batch management, recipe management, and data collection.
Strong leadership skills, with the ability to mentor and guide junior engineers and project teams.
Ability to perform listed responsibilities with limited oversight.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Engineering and Information Technology
Industries Software Development
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The Role The MES Technical Consultant will serve a key role owning the development and validation of core MES recipe objects and accompanying integrations. Additionally, this individual will also be well‑versed in Infobatch report development, web development, SQL, and ISA S‑95 standards. He/She will act as an escalation point contact for the MES, Infobatch, and ODH teams for complex initiatives.
Key Responsibilities
Lead the design, development, and implementation of MES core objects (custom behaviors, execution groups, etc.) using the Syncade platform.
Lead the design, development, and implementation of custom batch reports using the Infobatch platform.
Own the development and validation of complex web parts/application (ability to build custom tools using C# and web application using Node JS / Next JS, React).
Own the development and validation of complex labeling solutions (Crystal reports, Infobatch reports).
Provide technical leadership and guidance to junior engineers and project teams.
Deep understanding of Syncade database schema and adept at authoring SQL queries for ad‑hoc data needs.
Install, configure and maintain Manufacturing Execution Systems utilizing industry best practices.
Participate in the technical transfer of new products and processes from Tech Dev into Manufacturing.
Identify opportunities to improve existing processes, equipment, systems, and infrastructure by utilizing industry best practices.
Directly support operations with troubleshooting and issue resolution with respect to computer and automation systems.
Participate in validation activities with IT, Manufacturing, and QA related to implementation and ongoing support.
Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
Execute tasks precisely as defined in internal guiding documents including SOPs and work instructions.
Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
Ensure compliance with regulatory requirements and industry standards.
Stay up‑to‑date with emerging trends and technologies in MES engineering.
Troubleshoot and resolve technical issues related to MES systems and processes.
Required Background
Education: A bachelor’s degree in Engineering, Computer Science, or other technical degree.
Experience: Minimum 7+ years authoring and/or executing MES electronic batch records in the pharmaceutical or biotech industries.
Deep understanding of Syncade database schema and ability to author complex queries for ad‑hoc data needs.
Web development skills: Node JS, Next JS, React, Node‑RED, Flow Fuse.
Database skills: SQL, GraphQL.
Demonstrated aptitude or ability to learn GxP regulations, understanding of Good Automated Manufacturing Practices (GAMP) and Computer System Validation (CSV).
Experience designing recipes based on ISA 95 and ISA 88 standards and best practices.
Experience with software development and programming languages such as C#, Java, or SQL.
Strong knowledge of MES concepts, including batch management, recipe management, and data collection.
Strong leadership skills, with the ability to mentor and guide junior engineers and project teams.
Ability to perform listed responsibilities with limited oversight.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Engineering and Information Technology
Industries Software Development
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