MES Engineer

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, ISA S-95 standards will be 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. Owns Development and Validation of complex web

parts/Application (Ability to build custom tools using C# and web application using

node JS/ next JS, react) Owns 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 adhoc data needs

Install, configure and maintain Manufacturing Execution Systems utilizing industry

best practices Participate in the Technical Transfer of new products and process

from Tech Dev and 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 Participates in validation

activities with IT, Manufacturing, and QA related to implementation and on-going

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 but not limited to

standard operating procedures (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

processesRequired Background:

Education: A bachelor s degree in Engineering, Computer Science, or other

Technical degree.

Experience: A minimum 7+ years of experience authoring and/or execution of MES

electronic Batch Records. A minimum 7+ years of experience in the pharmaceutical

or biotech industries Deep understanding of Syncade Database schema and

ability to author complex queries for adhoc data needs Web development skills:

Node JS, Next JS, React, node-Red, Flow Fuse Database skills: SQL, GraphQL

Demonstrated aptitude or ability to learn to gain a strong understanding of GxP

regulations An 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 A successful individual will be able to perform

the listed responsibilities with limited oversight