Systems Engineer

Job Purpose

As the use of Manufacturing Execution Systems (MES) grows within the life sciences sector, we are looking for an experienced Senior Systems Engineer to join our expanding MES team. The candidate will be based on-site at a pharmaceutical multinational corporation (MNC) and will play a critical role in the execution phase of MES projects. Responsibilities include providing engineering support, troubleshooting, managing validation documents (IQ/OQ/PQ), and offering GoLive support to ensure seamless system integration and operation.

Key Responsibilities

MES System Troubleshooting & Support

· MES & ERP Troubleshooting: Identify and resolve issues in recipe execution and recipe authoring within MES and ERP systems.

· Change Control Documentation: Collaborate with QA to ensure approved change control documentation is in place for all MES system updates and modifications.

System Design, Testing & Validation

· Design & Validation: Design, write, and execute high-quality test and validation protocols, risk assessments, and system documentation, ensuring compliance with cGMP standards.

· Recipe Creation & Modifications: Create and update MES and ERP recipes, worksheets, and equipment/material specifications, including phase transition logic, to ensure alignment with system processes.

· Process Alignment: Ensure MES processes are properly aligned with equipment, cleaning, and product procedures.

Training & Knowledge Sharing

· MES Training: Provide comprehensive training to site personnel on MES-related roles, including system access, and ensure cross-training within the MES team.

· Governance & Issue Management: Participate in MES knowledge exchanges and governance meetings, managing issues, workarounds, and fixes as they arise.

System Upgrades & Maintenance

· System Upgrades: Collaborate with IT to manage MES system upgrades, patching, and hardware support, including system security and access.

· Hardware Support: Ensure maintenance and periodic upgrades of MES hardware such as printers, scales, scanners, and barcode labelers to maintain operational efficiency.

Continuous Improvement & Documentation

· Continuous Improvement: Contribute to continuous improvement initiatives aimed at enhancing the quality, safety, environmental, and production systems on-site.

· Documentation & Compliance: Ensure all activities and changes are thoroughly documented in compliance with cGMP and industry standards.

Requirements

· MES Expertise: Hands-on experience with MES systems such as Werum PAS-X, Aspen, Syncade, Siemens MES (Camstar, Opcenter, Simatic IT), including full application configuration and interfacing with SAP and automation systems.

· Pharmaceutical Process Knowledge: In-depth understanding of pharmaceutical business processes, including chemical manufacturing (W&D, solid bulk manufacturing, packaging) and biopharma operations.

· Batch Record Creation: Experience creating Master Batch Records within Werum PAS-X.

· Industry Standards: Strong knowledge of S88 and ISA S95 industry standards, as well as experience with GAMP lifecycle and pharmaceutical quality management processes.

· Communication & Collaboration: Excellent communication skills with the ability to collaborate effectively with internal teams and external groups.

· Project Experience: Demonstrated experience working on projects in pharmaceutical or biotechnology environments.

This role offers an exciting opportunity to be at the forefront of MES development in the life sciences industry while contributing to the success of critical manufacturing projects.