MES / CSV Specialist

Roles & Responsibilities

Primary Objective / Purpose

To architect, implement, and support the digital infrastructure necessary for automated manufacturing operations and uncompromised data integrity.

Key Responsibilities

. Deploy and maintain the Manufacturing Execution System (MES).

. Architect data integration between equipment and enterprise systems.

. Champion plant automation and electronic/digital batch records.

. Enforce data integrity and strict adherence to ALCOA+ principles.

. Design and deploy real-time manufacturing analytics and dashboards.

Key Deliverables

. MES configurations

. Digital batch records

. Manufacturing analytics dashboards

. Data integrity compliance reports

Required Skills & Qualifications

. Degree in Computer Science, IT, or Engineering.

. Experience with MES, DCS, and SCADA systems.

. Deep knowledge of GAMP 5 methodologies and CSV.

. Understanding of 21 CFR Part 11 and cybersecurity.