MES ENGINEER

Are you an experienced MES Engineer looking for a new challenge with a global medical products and technologies company? Do you have experience in quality and compliance in MES design, deployment and usage? Does a remote opportunity with some travel opportunities excite you? If you want to challenge yourself and progress your career in life sciences, don't hesitate and apply today!

Job Description

Our client requires a quality and compliance focused MES Engineer to play a pivotal role in bridging the gap between the MES implementation team and business quality stakeholders across global manufacturing sites. This position is responsible for ensuring that quality and compliance requirements are fully embedded into the MES design, deployment, and usage. You will drive the standardization and harmonization of quality processes, digital batch record structures, and validation approaches across sites. In addition, this role will define the roadmap for integrating quality test equipment with MES and lead the development of regulatory and validation documentation required for global rollout. The ideal candidate combines strong quality and compliance expertise with a deep understanding of MES systems and a collaborative approach to aligning cross-functional teams under a unified quality framework.

Responsibilities

• Act as the primary liaison between MES implementation teams (IT and MES COE) and business stakeholders to ensure quality requirements are well integrated into the MES application.
• Lead efforts to streamline, standardize, and harmonize production / quality-related processes, batch record structures, and documentation across all manufacturing sites using MES.
• Drive cross-site alignment on production / quality workflows, ensuring a unified approach to digital batch records and electronic quality management.
• Provide signon off on global MES template and enforce sites to follow the standardized approach.
• Define and develop the integration roadmap for quality testing equipment (e.g., LIMS, PAT, lab devices) with MES platforms.
• Establish and maintain standard validation and process qualification criteria for MES rollouts in regulated environments (e.g., GxP).
• Collaborate with global and site teams to ensure regulatory compliance, including preparation and review of validation protocols, user requirement specifications (URS), and other quality documentation.
• Contribute to the creation and maintenance of regulatory and validation documentation (CCR, MVP, CSV, IQ / OQ / PQ, etc.) as part of the global MES deployment strategy.
• Support change management, training, and communication initiatives to drive adoption and sustainment of MES quality standards.
• Participate in audits and inspections to ensure MES systems and quality processes meet compliance standards.

Requirements

Benefits

Location : remote, Ireland or UK