Position Title: MES Analyst - IT Manufacturing

Reporting To: IT Manufacturing & Quality Associate Director

A leading pharmaceutical company is establishing a state-of-the-art Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be one of the most technically advanced manufacturing sites, featuring cutting-edge manufacturing technologies, advanced data collection, and analytics platforms that aim to enhance safety, quality, productivity, and overall process performance.

Main Purpose and Objectives of the Position:

The MES Analyst will support and develop Manufacturing Execution System (MES) electronic batch records, logbooks, and associated tools, as well as system interfaces, to meet the business's operational needs. This role involves deploying and maintaining systems, analyzing information, and designing or implementing new solutions or enhancements to existing systems following company standards and industry best practices.

Key Duties and Responsibilities:

• Develop, modify, and enhance business applications or systems to meet business needs.
• Analyze business processes to recommend or implement changes to systems or procedures.
• Respond to user requests for specialized support, data extraction, and enhancements. Design and implement new systems, reports, and procedures while documenting and training users.
• Coordinate with vendors, corporate teams, or global personnel to manage updates or enhancements for purchased, outsourced, or enterprise-level applications. Provide user training for system updates.
• Act as a liaison between local IT teams and corporate systems groups to ensure smooth communication and alignment.
• Communicate system changes and ensure necessary updates are reflected in operational procedures.
• Identify, recommend, and implement application software solutions, whether custom-built or commercial off-the-shelf (COTS).
• Work across all phases of the system development life cycle (define, design, and deliver solutions) in compliance with company guidelines.
• Prepare project justifications, scope, and timelines, ensuring projects are completed according to these specifications.
• Oversee technical testing and installation with business users and technical teams.
• Provide user training, documentation, and post-implementation support for new applications and systems.
• Ensure compliance with Computer Systems Validation policies, standards, and practices.
• Address and resolve existing issues with business applications and systems.
• Interview users to identify system or data-related problems and revise applications or procedures accordingly.
• Coordinate problem resolution with vendors and corporate teams for third-party or global applications.
• Follow established IT department problem management processes.
• Collaborate with systems operations, desktop support, and telecommunications personnel to troubleshoot and apply fixes.
• Identify root causes of issues and implement corrective actions to prevent recurrence.
• Adhere to IT policies and procedures to ensure alignment with the organization's systems architecture strategy.
• Maintain systems and applications on supported versions, ensuring they remain up-to-date.
• Prioritize and manage Life Cycle Management (LCM) activities, ensuring compliance of supported systems.
• Coordinate and support the installation of system patches, fixes, and new versions, overseeing testing and communication with business users.
• Maintain ongoing communication with application vendors or solution providers to stay updated on their product direction and negotiate support for new software packages.
• Engage with customers regularly to manage project priorities and ensure business needs are met.
• Serve as the point of contact between the IT team and business stakeholders, ensuring clear communication.
• Train and assist users in effectively utilizing business applications.
• Keep management and customers informed of project progress through regular reports and status updates.
• Collect data and statistics on system performance and report on problems and requests.
• Prepare and provide management with project plans and status updates.
• Stay current on technology trends and apply new knowledge in areas such as Digital Plant and Industry 4.0 (IoT).
• Provide consulting and cross-training to other analysts and technicians.
• Participate in department meetings and required training, complying with all learning and development plans.
• Represent the department in cross-functional and global teams or forums as required.

Required Skills and Qualifications:

• Bachelor's Degree in Information Technology, Computer Science, Engineering, or a related field (Level 8 or equivalent).
• Minimum 5 years of experience in manufacturing, preferably in pharmaceutical or other regulated industries.
• Experience with Manufacturing Execution Systems (Syncade, PharmaSuite, Pas-X) is required.
• Knowledge and experience in Computer Systems Validation in cGMP-regulated environments.
• Familiarity with System Development Life Cycle (SDLC) methodologies.
• Strong understanding of cGMPs and Microsoft Office tools.
• Proven project management and leadership skills.

For further information on this role please contact Hannah Browne +353864409255 or email careers@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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