At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Title: Senior MES Engineer - IT Manufacturing
Reporting To: Associate Director - IT Manufacturing
Location: Full-time on-site in Raheen, Limerick
Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly's most technically advanced manufacturing site and will include next generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance.
Main Purpose and Objectives of Position:
The role will support and develop Manufacturing Execution System (MES) electronic batch records and logbook, associated tools, and system interfaces to fulfill business needs. Deploys existing systems, analyzes information, designs, programs, and/or implements new systems or enhancements to existing systems in accordance with company standards and guidelines.
Key Duties and Responsibilities:
1. Work within a team to analyze business processes and needs to recommend or implement changes to systems and/or procedures.
2. Work with local and global IT groups, automation and operations teams to support delivery of manufacturing solutions.
3. Work with site business areas and IT architects to implement solutions to meet business needs.
4. Understand how the manufacturing execution systems and processes integrate with other critical systems like EWM (Extended Warehouse Management) and Delta V.
5. Provide training, documentation, and post-implementation support to users of the new application and/or systems.
6. Coordinate or perform technical testing and installation with appropriate users and systems personnel. Prepare project justification, scope, and timeline, ensuring compliance with these commitments.
7. Ensure compliance with Computer Systems Validation policies, standards, procedures, and/or practices.
8. Create and/or follow applicable procedures and standards. Ensure support projects and/or requests align with the site strategy for applications architecture.
9. Participate and/or represent departments in cross-functional, global, and/or departmental teams and forums as requested.
10. Support site readiness activities to enable site start-up and ongoing operations.
Ability to:
1. Communicate effectively and build relationships cross-functionally.
2. Take initiative to identify and drive improvements.
Requirements:
1. Bachelor's Degree in Information Technology, Computer Science, Engineering, or related field (Level 8 or equivalent).
2. 5+ years' experience in manufacturing, preferably in pharmaceutical or other regulated industries.
3. Experience with Manufacturing Execution System platforms (Syncade, PharmaSuite, Pas-X) and Computer Systems Validation in cGMP regulated operations.
4. Knowledge of System Development Life Cycle.
5. Understanding of cGMP regulations.
6. Proficiency in Microsoft Office tools.
7. Project Management and leadership skills.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself
Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume, please complete the accommodation request form. Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, or any other protected status.
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