Title: Specialist Information Systems (Quality & Laboratory Systems)
Location: Dun Laoghaire, Dublin, Ireland
The candidate will provide support for existing Quality and Laboratory information systems and will lead the implementation of new Quality and Laboratory information systems. The individual will be capable of providing technical leadership to the site while ensuring that new initiatives are well defined, have a valid business case and are aligned with similar initiatives within the company. Ability to demonstrate technical, project and interpersonal skills, including but not limited to the following: client interfacing and resolution of client concerns, project definition and business case development, proactive support and resolution of issues, technical guidance from concept to delivery, system delivery, commissioning, and validation.
* Develop and support plans for systems including any required contracts with vendors or third parties, ensure all parties are aware of their responsibilities.
* Ensures that systems are robust, reliable, and available to meet business demand.
* Ensures that systems are maintained in a compliant manner according to the IS quality system.
* Ensures systems have appropriate disaster recovery plans and processes including contingency plans.
* Develop lifecycle plan for Quality and Laboratory Systems.
* Proactively engage with Quality and Laboratory teams to encourage the use of technology to maximize efficiency, capacity and reliability or operations.
* Develop innovative approaches to solve business challenges with current or new technology.
* Plan and execute Quality & Laboratory information systems projects including the building configuration of PCs for use in a GLP environment according to GAMP 5 and CFR 21.
* Coach system users in the complaint and efficient use of their systems.
* Aligns with relevant corporate business and IS teams to ensure that IS strategy for Quality and Laboratory systems is aligned with the company's goals and standards.
Education and Skills:
* Bachelor's degree in engineering, Information Systems, Computer Science, or the Life Sciences.
* 5 years' experience providing Quality and/or Laboratory information systems solutions and support to manufacturing organizations in the biotechnology or pharmaceutical industries.
* Experience with Empower CDS, Gen 5, Tecan, Maldi Biotyper, Tiamo, LMES, Sample Manager LIMS, Laboratory Analytical Equipment, and instruments and Trackwise will be an advantage.
* Candidates must have demonstrated experience in the delivery and management of information systems in addition to a working knowledge of GAMP software development lifecycle, and appropriate development methodologies for information systems.
* Individual must be able to work independently with minimal supervision.
* Customer relationship management skills.
* Critical thinking skills
* Strong technical and organizational communication, coordination, and meeting facilitation skills.
* Day to day vendor management experience
* Past experience working in a global environment
* Experience scoping, defining, planning, implementing, and documenting business opportunities.
* Client management skills - ability to work with internal business clients to understand their business processes, manage scope of work expectations and suggest / recommend IS solutions.
* Leadership, project management, communication, analysis, customer service, change management and interpersonal skills (e.g., conflict resolution) and demonstrate ability to function in a matrix team environment.
* Proven delivery of a completed system or application as part of a project or developer's team, preferably with an industry partner.
* Knowledge of System Architecture including underlying infrastructure and the structure of software solutions.
* Ability to master, with minimal support, new IS technologies and processes.
* Effective written and verbal communication skills.
* Excellent analytical, problem-solving, business analysis and decision-making skills.
* Able to multi-task and stay focused on priorities in a fast-paced environment to meet deadlines, including the ability to be comfortable and function effectively in an environment of ambiguity.
* Strong team player who is able to collaborate with colleagues on complex tasks and can provide leadership through influence to achieve the required results.
* Understanding of business intelligence and reporting technologies.
* Ability to participate/support efforts being run across multiple sites to ensure solutions satisfy local requirements.
* Experience with Enterprise systems, validation, testing and change control.
* Position may require travel
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.