MES Engineer: Drive Drug Product Manufacturing

Katalyst-Healthcares-; Massachusetts; In loco; USD 100.000 - 140.000; Tempo pieno

Descrizione del lavoro

Creative Solutions Services, LLC seeks a MES Engineer to design, develop, implement and manage MES within Drug Product manufacturing. Translate processes into robust MES, ensure GDP/GxP compliance and integrate with ERP, LIMS and automation platforms.

Role involves configuring Tempo/Syncade MES, creating modular templates per ISA 88/95, supporting validation, and developing data dashboards for operational decisions. Collaboration and data integrity are essential.

Competenze

• Bachelor's degree in engineering, computer science, or related technical field.
• 2–4 years of MES experience, preferably in Drug Product manufacturing.
• Basic understanding of GxP regulations, GAMP, and CSV.

Mansioni

• Assist in design and configuration of Tempo MES solutions for eBRs.
• Develop modular MES templates based on ISA 88/95 standards.
• Perform impact assessments for recipe changes and system updates.
• Collaborate with cross-functional teams to gather requirements and specs.
• Provide day-to-day MES support and troubleshoot issues.

Descrizione del lavoro

Summary:

The MES Engineer will play a critical role in supporting the design, development, implementation and management of the Manufacturing Execution Solutions (MES) within the organization's Drug Product manufacturing area. This role involves translating manufacturing processes into robust MES solutions, ensuring compliance with GxP standards, and integrating MES with other enterprise systems and automation platforms to streamline operations.

Roles & Responsibilities:

• Assist in the design and configuration of Tempo MES solutions, including electronic batch records (eBRs), under the guidance of senior engineers.
• Contribute to the development of modular, scalable, and reusable MES recipe templates based on ISA 88/95 standards.
• Perform impact assessments for recipe modifications and system updates, ensuring adherence to GxP requirements.
• Collaborate with cross-functional teams to gather user requirements and define functional specifications for MES functionalities.
• Assist in recipe design and authoring electronic batch records (eBR) to develop modular, scalable and reusable MES recipe and equipment workflow templates following ISA 88/95 standards.
• Perform root cause analysis and resolve MES issues related to system configuration, recipe design, or integration failures.
• Support efforts to integrate MES with other enterprise systems, such as ERP, LIMS, and automation platforms, using industry-standard protocols like OPC or RESTful APIs.
• Assist in the development of data visualization tools and reporting dashboards to support operational decision-making.
• Possess technical knowledge in DCS, automation, and systems integration, including the design and management of data dashboards, label management systems, and reporting tools.
• Provide day-to-day technical support for MES system users, assisting in troubleshooting and resolving recipe or system-related issues.
• Participate in technical transfer activities to ensure smooth onboarding of new products and processes into manufacturing.
• Support off-hours manufacturing operations as needed to address critical MES-related issues.
• Ensure compliance with Good Documentation Practices (GDP), GxP regulations, Data Integrity guidelines and company policies during all MES-related activities.
• Participate in validation activities to support the implementation and ongoing maintenance of MES systems.

Required Qualifications:

• Bachelor's degree in Engineering, Computer Science, or a related technical field.
• 2-4 years of experience with MES systems, preferably some in Drug Product manufacturing in pharmaceutical or biotechnology environments.
• Basic understanding of GxP regulations, GAMP guidelines, and Computer System Validation (CSV).
• Exposure to MES platforms such as Tempo, Syncade, or equivalent systems is preferred.
• Familiarity with basic programming concepts or languages like SQL, Python, or C#.
• General knowledge of manufacturing processes, automation systems, and systems integration principles.
• Strong problem-solving and analytical skills with a willingness to learn and adapt quickly.
• Effective communication and collaboration abilities to work in cross-functional teams.
• Commitment to maintaining compliance with regulatory and internal standards