Digital Record (MES) Senior Specialist - Brinny, Hybrid

Are you ready to bring your expertise, innovative thinking, and energy to a role that promises substantial impact? We invite you to join our team at our state-of-the-art Brinny site, as a Digital Records MES (Manufacturing Execution System) Senior Specialist within our Digital Records Design Hub. This is more than just a job. It's an exciting opportunity to be part of a team that values leadership, and an invitation to contribute to our purpose of delivering innovative health solutions worldwide.

Your Core Responsibilities 

• As a key player, you'll actively participate in the Tier process, untangling technical issues and supporting MES-related components of our manufacturing process. 
• You'll take charge of managing MES Systems Version 3.1.8 HF5, ensuring compliance with our company policies, quality regulations, and industry standards. 
• Overseeing vendor performance and contracts will fall under your purview, as well as supporting investigations by troubleshooting MES problems. 
• You'll get to develop and maintain MES recipes and capabilities, collaborating with other technical functions to ensure reliable performance. 
• You'll ensure the timely completion of the Update/Change Process, keeping aligned with quality standards. 
• Your role will also involve MES administration and maintenance. You'll keep our automation systems in a validated state and identify opportunities for improvement. 
• You will be responsible for developing and updating SOPs, conducting MES training, and ensuring document compliance with SDLC requirements. 
• As part of our global team, you'll represent our company's MES team at the corporate level, contributing to our overall mission and vision. 

Who You Are 

You are ready if you have: 

• Level 8 degree in a technical field (engineering or science) or equivalent 
• We need someone who can manage multiple priorities and escalate issues when necessary. 
• A proven ability to work cross-functionally, delivering technical solutions to MES issues, is key. 
• Strong problem-solving and troubleshooting skills will be critical to your success in this role. 
• Knowledge of Irish, European, and International regulatory/code requirements is a must-have. 
• Proficiency in Microsoft Office and job-related computer applications, along with skills in report and policy writing, will be essential. 

Nice to have, but not essential: 

• Experience in the application of Lean Six Sigma Methodology would be a distinct advantage. 
• If you've worked in Pharmaceutical and Biotechnology manufacturing processes before, that's even better.