York Solutions, LLC
Description Overview: We are seeking an MES Engineer with expertise in Rockwell FactoryTalk Production Centre (FTPC) and Pnuts to support and enhance our Manufacturing Execution System (MES) capabilities. This role will focus on system configuration, integration, customization, and troubleshooting to ensure seamless production execution, data integrity, and regulatory compliance within a medical device manufacturing environment.
Location: Onsite in either Maple Grove, MN or Plano, TX or Chicago, IL
Responsibilities: MES Development & Support Design, develop, and configure Rockwell FTPC solutions to meet manufacturing and regulatory requirements. Develop and optimize MES workflows, electronic batch records (EBRs), and work instructions to enhance operational efficiency. Utilize Pnuts for MES-related scripting, data manipulation, and automation to improve system performance. Troubleshoot and resolve MES-related hardware, software, and integration issues in collaboration with cross-functional teams. Support MES validation and qualification efforts, ensuring compliance with FDA, GMP, and ISO 13485 regulations. System Integration & Data Management Integrate MES with PLCs, SCADA, ERP (SAP), and LIMS systems for seamless data exchange. Develop and maintain custom Pnuts scripts to support data processing, workflow automation, and system integrations. Maintain and optimize data collection, reporting, and visualization tools to support manufacturing analytics. Work with IT teams to ensure system security, backup, and disaster recovery plans are in place. Continuous Improvement & Compliance Participate in continuous improvement initiatives to enhance MES system functionality and efficiency. Ensure all MES implementations align with 21 CFR Part 11, cGMP, and other regulatory standards. Develop and maintain technical documentation, SOPs, and user training materials for MES-related processes.
Required Qualifications: Bachelor’s degree in Engineering, Computer Science, or a related field. 3-5 years of experience working with MES solutions, preferably in the medical device, pharmaceutical, or life sciences industries. Hands-on experience with Rockwell FactoryTalk Production Centre (FTPC) configuration, development, and support. Proficiency in Pnuts programming language for custom MES development, scripting, and system integration. Strong knowledge of SQL databases, scripting (VB, Python, JavaScript), and REST APIs for MES integration. Familiarity with PLC/SCADA systems, OPC communications, and industrial automation protocols. Understanding of GMP, FDA 21 CFR Part 11, and ISO 13485 compliance requirements. Experience with validation, qualification (IQ/OQ/PQ), and CSV documentation.
Preferred Qualifications: Experience integrating MES with ERP (SAP) and LIMS systems. Knowledge of reporting tools (Power BI, SSRS, or Tableau) for manufacturing data analytics.
Benefits: York Solutions Offers a generous benefits package for eligible full-time employees: BCBS Medical with 3 Plans to choose from (PPO and High deductible PPO plans with Health Savings Program) Delta Dental plan with 2 free cleanings and insurance discounts Eye Med Vision with annual check-ups and discounts on lens Life and Accidental Death Insurance paid by company John Hancock 401(k) Retirement Plan with discretionary company match up to 5% Voluntary Insurance programs such as: Hospital Indemnity, Identity Protection, Legal Insurance, Long Term Care, and Pet Insurance. Flexible work environment with some remote working opportunities Strong fun and teamwork environment Learning, development, and career growth
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Location: Onsite in either Maple Grove, MN or Plano, TX or Chicago, IL
Responsibilities: MES Development & Support Design, develop, and configure Rockwell FTPC solutions to meet manufacturing and regulatory requirements. Develop and optimize MES workflows, electronic batch records (EBRs), and work instructions to enhance operational efficiency. Utilize Pnuts for MES-related scripting, data manipulation, and automation to improve system performance. Troubleshoot and resolve MES-related hardware, software, and integration issues in collaboration with cross-functional teams. Support MES validation and qualification efforts, ensuring compliance with FDA, GMP, and ISO 13485 regulations. System Integration & Data Management Integrate MES with PLCs, SCADA, ERP (SAP), and LIMS systems for seamless data exchange. Develop and maintain custom Pnuts scripts to support data processing, workflow automation, and system integrations. Maintain and optimize data collection, reporting, and visualization tools to support manufacturing analytics. Work with IT teams to ensure system security, backup, and disaster recovery plans are in place. Continuous Improvement & Compliance Participate in continuous improvement initiatives to enhance MES system functionality and efficiency. Ensure all MES implementations align with 21 CFR Part 11, cGMP, and other regulatory standards. Develop and maintain technical documentation, SOPs, and user training materials for MES-related processes.
Required Qualifications: Bachelor’s degree in Engineering, Computer Science, or a related field. 3-5 years of experience working with MES solutions, preferably in the medical device, pharmaceutical, or life sciences industries. Hands-on experience with Rockwell FactoryTalk Production Centre (FTPC) configuration, development, and support. Proficiency in Pnuts programming language for custom MES development, scripting, and system integration. Strong knowledge of SQL databases, scripting (VB, Python, JavaScript), and REST APIs for MES integration. Familiarity with PLC/SCADA systems, OPC communications, and industrial automation protocols. Understanding of GMP, FDA 21 CFR Part 11, and ISO 13485 compliance requirements. Experience with validation, qualification (IQ/OQ/PQ), and CSV documentation.
Preferred Qualifications: Experience integrating MES with ERP (SAP) and LIMS systems. Knowledge of reporting tools (Power BI, SSRS, or Tableau) for manufacturing data analytics.
Benefits: York Solutions Offers a generous benefits package for eligible full-time employees: BCBS Medical with 3 Plans to choose from (PPO and High deductible PPO plans with Health Savings Program) Delta Dental plan with 2 free cleanings and insurance discounts Eye Med Vision with annual check-ups and discounts on lens Life and Accidental Death Insurance paid by company John Hancock 401(k) Retirement Plan with discretionary company match up to 5% Voluntary Insurance programs such as: Hospital Indemnity, Identity Protection, Legal Insurance, Long Term Care, and Pet Insurance. Flexible work environment with some remote working opportunities Strong fun and teamwork environment Learning, development, and career growth
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