MES Engineer/Manager/Senior Manager

We are currently supporting a search for an MES Engineer/Manager/Senior Manager based in Kobe. Our client is a global healthcare leader in the life science industry, focused on discovering and delivering innovative medicines to patients worldwide. It is investing in new, state-of-the-art manufacturing capacity and expanding its existing facilities, with a strong focus on advanced automation and on minimizing environmental impact.

About the Role

Our client is transforming its manufacturing operations, and the Manufacturing Execution System (MES) is central to that effort. Several projects are underway to expand MES across its network, enable a newly developed Kobe manufacturing site to operate paperless, and modernize MES in established operations worldwide. In this role you will bridge business needs and technology to deliver MES solutions and other production systems successfully. You will build expertise in PharmaSuite, supporting, developing and validating global electronic batch records. You will work closely with global and site teams to ensure compliance with validation requirements and to address technical, operational and business challenges proactively. The role is based at the site, with occasional off-hours and weekend work and some international travel.

Responsibilities

MES Development and Integration * Develop and integrate common and site-specific MES components. * Create and maintain interfaces between MES and other internal systems. * Support start-up activities for MES solutions.

Bridging Business Needs and Technology * Evaluate functional requirements and translate them into technical solutions, within and beyond MES. * Work with site resources on replication and standardization to drive value. * Support, develop and validate global electronic batch records to meet business needs.

Validation and Documentation * Maintain project and validation documentation throughout lifecycle and release management. * Ensure compliance with validation requirements together with global and site teams.

Innovation and Vendor Collaboration * Evaluate new technologies and benchmark innovative solutions, both internal and external, and assess their implications for the existing footprint. * Maintain open communication with MES vendors to meet needs through the standard solution or functional packs. * Adapt the roadmap to site evolution, strategic direction and new trends or issues.

Requirements

• Bachelor's degree in engineering, computer science, information technology or a related technical field, or a minimum of 2 years of experience working with Manufacturing Execution Systems.
• Experience with an MES platform such as PMX, PharmaSuite, Syncade-DeltaV MES or Werum PAS-X (or similar) is strongly preferred.
• Understanding of GMP regulations and Computer System Validation principles (e.g. GAMP 5, 21 CFR Part 11, Annex 11) is preferred, as is experience authoring and validating Master Batch Records in a regulated environment.
• Excellent written and spoken Japanese and business-level written and spoken English.
• Strong collaboration skills across functions, with the ability to communicate effectively with technical and non-technical stakeholders.
• Creativity, analytical thinking and a proven ability to troubleshoot, manage multiple concurrent activities and adapt to changing priorities.
• Strong documentation skills and attention to detail, and a record of promoting safety, compliance and operational excellence.
• Experience serving as an escalation contact for vendors is preferred.

Notes: This position is based in Kobe City. You should live within a 90-minute commuting distance by public transport from Kobe or be willing to relocate. Rented company housing may be provided.