Vak Consulting

Position Title: MES Engineer
Location: Boston Area (On site in Norwood, MA)

Department: Internal DP Operations Systems Regulatory Relevance: GxP

Primary System: Apprentice Tempo MES

Role Overview:

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.

Key Responsibilities:

·       MES Support and Development:

o   Assist in the design and configuration of Tempo MES solutions, including electronic batch records (eBRs), under the guidance of senior engineers.

o   Contribute to the development of modular, scalable, and reusable MES recipe templates based on ISA 88/95 standards.

o   Perform impact assessments for recipe modifications and system updates, ensuring adherence to GxP requirements.

o   Collaborate with cross-functional teams to gather user requirements and define functional specifications for MES functionalities.

o   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.

o   Perform root cause analysis and resolve MES issues related to system configuration, recipe design, or integration failures.

·       System Integration and Analytics:

o   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.

o   Assist in the development of data visualization tools and reporting dashboards to support operational decision-making.

o   Possess technical knowledge in DCS, automation, and systems integration, including the design and management of data dashboards, label management systems, and reporting tools.

·       Operational Support:

o   Provide day-to-day technical support for MES system users, assisting in troubleshooting and resolving recipe or system-related issues.

o   Participate in technical transfer activities to ensure smooth onboarding of new products and processes into manufacturing.

o   Support off-hours manufacturing operations as needed to address critical MES-related issues.

·       Compliance and Documentation:

o   Ensure compliance with Good Documentation Practices (GDP), GxP regulations, Data Integrity guidelines and company policies during all MES-related activities.

o   Participate in validation activities to support the implementation and ongoing maintenance of MES systems.

Required Qualifications:

·       Education:

o   Bachelor’s degree in Engineering, Computer Science, or a related technical field.

·       Experience:

o   2-4 years of experience with MES systems, preferably some in Drug Product manufacturing in pharmaceutical or biotechnology environments.

o   Basic understanding of GxP regulations, GAMP guidelines, and Computer System Validation (CSV).

·       Technical Skills:

o   Exposure to MES platforms such as Tempo, Syncade, or equivalent systems is preferred.

o   Familiarity with basic programming concepts or languages like SQL, Python, or C#.

o   General knowledge of manufacturing processes, automation systems, and systems integration principles.

Additional Competencies:

• 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.