eBRS Technical Lead

Position Overview

We are seeking an experienced and motivated eBRS Tech Lead to become part of our Smart Manufacturing initiative, supporting a global client in the pharmaceutical sector. This role involves spearheading the comprehensive technical delivery of an Electronic Batch Record System (eBRS) utilizing the Aspen V14 MES platform, facilitating the digital transformation of pharmaceutical manufacturing in alignment with the client's Smart Manufacturing 2030 strategy.

This is a remarkable opportunity to engage at the forefront of innovative manufacturing technology while adhering to life sciences regulatory compliance, implementing integrated solutions across MES, SAP, and DCS systems while upholding the utmost standards of GxP compliance and data integrity.

Core Responsibilities

• Develop and document eBRS recipes and workflows within Aspen V14, ensuring alignment with core library usage and quality process flow (QPW) guidelines.
• Configure and oversee business processes for material management and flow, as well as equipment management, which includes the Equipment Logbook (ePEL) and Aspen production record systems.
• Facilitate the integration of SAP with eBRS, ensuring effective communication with DCS (Distributed Control System) to support batch creation through Campaign Manager, process orchestration via EDM, and batch data recording via APRM.
• Implement and set up EDM (Event Driven Module) to manage real-time manufacturing events, process activity orchestration, and stock reporting to SAP.
• Guide the configuration of Aspen MES modules: MOC, mMDM, APRM, AFW IP.21, and Aspen Mobile.
• Manage ADO story and task assignments to support the Design, Testing, and Go-live phases.
• Oversee ServiceNow change activities and manage the Kneat system for defect tracking during testing.
• Lead smart manufacturing initiatives aimed at achieving the 2030 digital transformation roadmap.
• Ensure compliance with GxP standards, site validation protocols, and production stage requirements for the GSK client site.
• Supervise the primary site eBRS design, configuration, and ongoing improvement efforts.
• Provide mentorship to team members on best practices related to recipe development, material and equipment management, and system integrations.

Essential Skills & Qualifications

• Aspen MES Platform: Thorough expertise in the architecture and modules of Aspen V14, including APEM (MOC), AFW, mMDM, IP.21, Aspen Mobile, and A1PE.
• eBRS Recipe Design: Significant experience in crafting eBRS recipes, including SQL syntax for generic and multi-process recipe development and production record management.
• Application Debugging: Advanced ability to analyze MOC and API debug outputs to identify and resolve issues in recipe solutions.
• SQL / Code Writing: Proficient in writing SQL code supported by the Aspen V14 platform.
• BPL/RPL/MR Design: Expertise in BPL, RPL, and MR design to meet business process requirements.
• Vendor Management: Demonstrated experience collaborating with product vendors to implement platform fixes and enhancements.
• Material & Equipment Management: Comprehensive knowledge of material management, equipment management, and mMDM configuration.
• SAP & DCS Integration: Expertise in SAP ↔ eBRS integration, complete Delta V DCS communication setup, and design of Zebra printer labels.
• EDM & Smart Manufacturing: Practical experience with EDM configuration and initiatives related to Smart Manufacturing 2030.
• GxP & Validation: In-depth understanding of GxP standards, site validation protocols, and production stage requirements.
• Tooling: Proficient in using ADO, ServiceNow, and Kneat for managing projects and defects.
• Agile Delivery: Proven ability to deliver solutions using Agile methodologies.
• Leadership & Communication: Exceptional project leadership and cross-functional communication capabilities.

Desirable Skills

• Familiarity with additional MES platforms or advanced Aspen modules.
• Understanding of Industry 4.0 technologies and digital twin concepts.
• Previous experience in primary API manufacturing with insights into relevant business processes.
• Experience with Pub/Sub messaging architectures.
• Experience generating Reports and Dashboards using A1PE.
• Exposure to RPA, Test Automation, or AI/ML applications to enhance Aspen MES platform functionalities.

Educational Background

• A degree in Engineering, Computer Science, Information Technology, or a related field.
• Professional certifications in Manufacturing Execution Systems, GxP compliance, or similar areas are preferred.
• Willingness to travel as needed.