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Position Title: IT Professional - MES Analyst
Reporting To: Associate Director - MQ IDS
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:
Supports and develops Manufacturing Execution System (MES) electronic batch records and logbook, associated tools, and system interfaces to fulfil business needs. Deploys existing systems, analyses 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. Creates, modifies and/or enhances business applications and/or systems to satisfy business information demands.Analyses business processes and needs to recommend or implement changes to systems and/or procedures.Performs user requests for special support and/or extracts of data. Designs, programs and/or implements new systems, reports, screens and/or procedures. Documents and train users on these new systems and/or changes.Coordinates changes and/or enhancements with vendors and/or Corporate or affiliate personnel for purchased, outsourced, and/or Corporate or affiliate supported (global) applications. Train users on these changes and/or enhancements.Serves, as a liaison between local and corporate systems groups, IDS and local business users.Communicates changes applied to programs, which may require updates to current System Operations Area procedures.
2. Identify recommend and Implement application software solutions (custom or COTS).Works in all phases of systems development cycle (define, design and deliver solution) according to company and department guidelines.Prepares project justification, scope and timeline and ensures project complies with these commitments.Coordinates or performs technical testing and installation with appropriate users and systems personnel.Provides training, documentation, and post-implementation support to users of the new application and or systems.
3. Ensure compliance with Computer Systems Validation policies, standards, procedures and/or practices.Solves existing business applications and/or systems situations for his/her customers.Interview users to identify the applications, systems and/or data problems. Analyses this information and revises the applications logic and procedures (if applicable) to solve existing data processing difficulties.Coordinates problem resolution with vendors and/or Corporate or affiliate personnel for purchased, outsourced, and/or Corporate or affiliate supported (global) applications.Follows MQ IDS department problem management process.Assists Systems Operations, Desktops and/or telecommunications personnel on application of fixes and related troubleshooting.Identify root cause and action plan to avoid the same situation occurs.
4. Creates and/or follows MQ IDS applicable procedures and standards. Ensures support projects and/or requests are in accordance with the site strategy for applications architecture.
5. Keeps systems and/or applications on current and/or supported versions.Ensure LCM activities are prioritized, and supported systems are in compliance.Coordinates and/or supports the installation of systems and/or application patches, fixes, and new versions with business users and MQ IDS personnel. Leads the testing coordination for these patches, fixes, or new versions.Maintains communication with applications vendors and/or solution providers to be informed on their direction. Negotiates with them on the support for a new product or package.
6. Keeps close communications with customers during the development cycle or support phases of systems supported.Meets with customers on a regular basis (priorities meetings, one-on one meetings, group meetings, etc.)Take responsibility for making sure that business request and demands are met. Acts as liaison between the MQ IDS group and business customers.
7. Trains and/or assists systems users in the proper use of business applications.
8. Keeps IDS management and customers informed on the progress of work.Provides status reports through available tools (emails, meetings, presentations, etc.)Collects and provides data and statistics (measures) on systems and/or applications problems and requests.Prepares and provides management project plans to communicate project status.
9. Keeps up to date on technology trends.Must take the initiative to continually acquire technical (ie. Digital Plant, IoT 4.0, etc) and business knowledge (through self-educate & seminars) and apply this knowledge to the roleProvides consulting and cross training to other analyst and/or technicians.
10. Attends departmental/team meetings and required training for the position as required. Complies with assigned Learning Plan requirements
11. Participates and/or represents departments in cross- functional, global and/or departmental teams and forums as requested.
Ability to :
12. Establish positive interpersonal relations and interact effectively with people.
13. Work under occasionally supervision.
14. Memorize details and ideas.
15. Work under time pressure.
16. Make decisions.
17. Exercise good judgment in special situations.
18. Perform repetitive task.
Knowledge
19. Knowledge of System Development Life Cycle.
20. cGMP's.
21. Knowledge of Microsoft Office suite of tools.
22. Project Management and Leadership skills (highly recommended).
Experience Requirements:
23. Minimum 5 years experience in manufacturing, preferred in pharmaceutical or other regulated industries.
24. Manufacturing Execution System platform experience required (Syncade, PharmaSuite, Pas-X) Computer Systems Validation in cGMP regulated operations experience
Educational Requirements:
25. Bachelor’s degree in business administration with major in Computerized Information System, Computer Science, Programming or Engineering or equivalent.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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