MES Lead

Hobson Prior are looking for a MES Lead to join a brilliant organisation on a Permanent basis, located in Dublin, Ireland. Our Client is focused on delivering transformative medicines that improve the lives of patients.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• In this position, you will be responsible for Serve as the champion for the development of the Master Batch Record.
• Manage Master Batch Record (MBR) within MES solution with manufacturing, QA, CSV, MS&T teams.
• Collect MBR requirements.
• Determine MBR enhancement requirements with various product experts (operations, validation).
• Prepare master data, state diagrams, and equipment management updates.
• Establishing the standard set of instructions for site implementations Designing state diagrams in MES.
• Defining the specific process requirements for a given site.
• Developing URS and FDS, updating them and/or writing them.
• Creating, designing, and maintaining MBRs in accordance with industry standards.
• Ensure that MBR protocols are written according to best practices.
• Provide support for OQ and PQ execution with different interfaces (SAP, scales, etc.).
• During the validation process, provide guidance on issues related to MBRs.
• Troubleshoot and resolve defects during qualification and validation of Master Batch Records.
• Take advantage of the MES PharmaSuite by using it.
• Identify the requirements for MES and gather them.
• Determine MES enhancement requirements with product (operations, validation) experts.
• Provide support for the implementation of new software versions (IQ, OQ, PQ).
• Engage in end-user training activities as part of your job duties.
• A wide variety of other responsibilities may be assigned by the Director/Manager if deemed necessary by the Director/Manager.

Key Skills

• An understanding of the pharmaceutical business and cGMP manufacturing operations is required.
• An understanding of information systems would be an asset.

Requirements:

• A bachelor's degree in engineering or a related technical discipline is required.
• Background in Science, Quality, or Engineering.
• Five years' experience in Quality Assurance, Manufacturing, Engineering, IT/OT.
• An understanding of the pharmaceutical processes from a functional perspective.
• Experience in manufacturing/technical operations associated with GMP manufacturing and cGMP manufacturing standards.
• A minimum of two years' experience with Manufacturing Execution Systems would be an advantage.
• Rockwell FTPS experience is preferred.
• Communication skills and ability to influence at all levels.
• Work well in teams.
• A hands-on approach, self-reliant, and excellent problem-solver
• Fluency in English, French is advantageous.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.