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QC Lab Systems Engineer

  1. Dublin
  1. Contract
Competitive
  1. Compliance / Quality Assurance
01-12-2023
32560
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QC Lab Systems Engineer - Life Science - Dublin - 12-Month Contract 

Would you like to grow your career, whilst contributing to scientific innovations that are transforming patients’ lives? Our client, a globally renowned biotechnology organisation, and voted one of the top 10 best companies to work for in Ireland, is looking to recruit a QC Lab Systems Engineer to join their team.


Key Responsibilities: 
  • Develop/maintain processes/user workflows in lab systems to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met.
  • Collaborate with appropriate laboratory, manufacturing, analytical support and/or site/global IT teams to ensure needs and requirements are accurate in the lab systems.
  • Develop strategies and drive activity for harmonisation/standardisation of the lab system(s) to enable operational efficiencies in system maintenance, master/static data creation, enable consistent data reporting, and standard procedures/training on system use across the internal commercial QC sites.
  • Review method/specification change controls, identify lab system impact, and develop appropriate change actions required to support implementation of the change, including impact to interfacing systems. Collaborate with lab personnel, analytical support teams, and other relevant SMEs to assess impact to lab systems as needed.
  • Execute and document lab system user workflow creations/revisions through the appropriate change control process and/or verify changes executed by a team member are accurate associated within the lab system.
  • Design/Execute User Acceptance Testing for lab system application functionality changes.
  • Author, revise, and/or review procedural documents, such as SOPs and WIs and associated training content.
  • Develop/Monitor/Enhance KPIs that provide meaningful insights into team workload capacity/progress & customer support that identify and drive areas for business process improvements.

Qualifications and experiences: 
  • Minimum BS, preferably Masters in biological science or related field with at least 1-3 years of experience in biopharmaceutical technical operations.
  • Strong scientific background in analytical methods and processes related to biopharmaceutical bulk and finished products preferred.
  • Demonstrated knowledge or experience in use, development and/or management of Lab Data Systems, preferably in the MODA Lab Data System, to understand impact of changes to these systems and integrations.
  • Self-directed with a high degree of professional integrity, organisation, and attention to detail.
  • Strong interpersonal, oral, and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
  • Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organisation.
  • Strong project management and execution skills and can manage multiple projects and prioritise as needed.

If this role is of interest to you, please apply now! 

The candidate must have the rights to work in the location stated in the job advert.

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