Description
This Applications Support Engineer opportunity is to join a Global Biologics company on their billion dollar startup project in Dublin.You will be an essential part of the team and will be responsible for operational support of Enterprise Systems and other Applications deployed on site.
Working closely with business owners and the IT Applications Manager, you will be the liaison with corporate IT teams, responsible for technical aspects of Enterprise Systems/Applications such as SAP, DCA, Trackwise, Enablon, Kronos, Maximo, Vault, CCure, Workday and any other non-Laboratory-specific corporate systems required to support the project.
Your Responsibilities will be:
- You will be assigned to the Lab Office Canteen (LOC)/MPCC project, where you will have a project reporting line to assist with some of the Workstream initially. Post project, your position will transition to have Sitewide system owner responsibility for operations of IT Applications
- You will actively participate in the creation of project deliverables such as design documents, configuration build, and installation and validation activities as required by the IT Applications Manager.
- To deliver the communication system for the project.
- Assures all project work is completed in compliance with all Regulatory requirements including, Quality (cGLP/GMP's), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local/Federal Regulatory requirements.
- Support the IATL on schedules and budget development and control.
- Assist with the patching process.
- Assist and liaise with Global Security, Incident Management, Departments & Vendors on Application & System Security policies, prevention methods, threats and incidents as they arise.
- To ensure technical delivery of applications to meet business objectives.
- Act as Technical Support Specialist/Engineer for Enterprise/Business Applications/Systems.
- Responsible for regular communication between A&IT & multi-functional team stakeholders.
- Gathers input and coordinates with project team, Site or Global representatives to develop requirements.
- Participate in the turnover process to ensure compliance with the BMS standard.
- Contribute to a high-performance culture by recognizing and resolving issues as they arise.
- Bachelors or Master's Degree in Engineering/Information Systems/Computer Science or Life Science.
- 3-5 years' experience providing IT systems/application support in a highly regulated manufacturing industry (Bio-Technology/Pharmaceutical).
- Ensuring compliance with practices, policies, procedures, legal requirements and goals of project sponsors and approved methodologies, develop supporting documentation and monitor budget tracking/timeliness/scheduled resources.
- Thorough knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP, OSHA, EPA/EQB) required.
- Strong working knowledge of 21 CFR 11 compliance requirements as they relate to IT systems/Applications.
- Experience with few or all the following systems is Essential: SAP, Syncade, Trackwise, Enablon, Kronos, Maximo, Vault, CCure, corporate business applications, non-Laboratory-specific systems.
- Experience with designing information interfaces, data conversion, and network and infrastructure fundamentals.
- Good knowledge of databases, reporting, and analytic systems.
- Ability to keep work pace and meet deadlines. Good organizing and planning skills.
- Problem solver with a focus on achievement of overall project goals.
- Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilizing technical, project management, and business expertise.