System Validation Specialist

2 weeks ago


Galway, Galway, Ireland beBeeValidation Full time €90,000 - €120,000
System Validation Expert

Our organization seeks a seasoned system validation expert to ensure seamless integration of IT and OT systems. As a key advisor, you will play a vital role in maintaining regulatory compliance and quality standards.

Key Responsibilities:
  • Develop and execute comprehensive validation protocols for IT and OT systems.
  • Lead risk-based validation efforts aligned with GxP, FDA, and EU MDR requirements.
  • Collaborate with cross-functional teams to drive process improvements enhancing quality, compliance, and efficiency.
  • Utilize data analysis tools like Excel and Minitab to inform decision-making.

Requirements:

  • 5+ years of experience in computer system validation or software assurance in a regulated environment.
  • Proven expertise in developing validation plans, protocols, and risk assessments.
  • Strong understanding of IT/OT systems, including MES, SCADA, ERP, LIMS, and Data Historians.
  • Excellent communication and documentation skills.

Benefits:

  • Opportunity to work with a forward-thinking organization.
  • Chance to leverage your expertise to drive business growth.
  • Professional development opportunities.


  • Galway, Galway, Ireland beBeeValidation Full time €45,000 - €55,000

    System Validation SpecialistWe are seeking a skilled System Validation Specialist to lead validation efforts across our clients' critical systems. You will act as a key advisor to IT, Operations, and QA teams, ensuring systems meet regulatory and quality standards.Key Responsibilities:Lead validation and Computer Software Assurance (CSA) for IT and OT...


  • Galway, Galway, Ireland beBeeValidation Full time €60,000 - €80,000

    Job Title: Data Validation SpecialistWe are seeking a skilled professional to lead validation and assurance efforts across critical systems.About the Role:Lead validation and Computer Software Assurance (CSA) for IT and OT systems, ensuring compliance with regulatory standards.Develop and execute protocols (IQ/OQ/PQ/PPQ, Test Method Validation) using...

  • Validation Specialist

    2 weeks ago


    Galway, Galway, Ireland beBeeMedicalDevice Full time €60,000 - €90,000

    Medical Device Validation SpecialistWe are seeking a highly skilled and experienced Medical Device Validation Specialist to join our team. As a key member of our team, you will be responsible for ensuring the quality and safety of our medical devices.Your primary focus will be on validation and quality assurance of site equipment, utilities, processes and...


  • Galway, Galway, Ireland beBeeValidation Full time €80,000 - €100,000

    IT Validation SpecialistWe are seeking a skilled IT validation professional to lead system assurance efforts across our clients' critical systems.You will act as a key advisor to IT teams, ensuring systems meet regulatory and quality standards.This is a dynamic, hands-on role supporting both enterprise IT environments.Key Responsibilities:Lead system...


  • Galway, Galway, Ireland beBeeDataValidator Full time €80,000 - €100,000

    Job OverviewAs a skilled professional in data validation and assurance, you will lead efforts to ensure systems meet regulatory and quality standards.You will collaborate with IT, Operations, and QA teams to implement robust validation processes.This dynamic role supports enterprise IT and operational technology environments, requiring expertise in both...


  • Galway, Galway, Ireland beBeeValidation Full time €60,000 - €80,000

    Role OverviewThe primary objective of this QA Validation Engineer position is to oversee the development and maintenance of a comprehensive site validation program for an esteemed client.Key Responsibilities:Coordinate, direct and participate in the validation and quality assurance of site equipment, utilities, processes and software in compliance with...


  • Galway, Galway, Ireland beBeeLeadership Full time €100,000 - €120,000

    Job Role: Lead System Assurance SpecialistSolutions providers are developing next-generation medical technologies to address abnormal heart rhythms. Our innovative portfolio offers solutions that advance and enhance care.Collaborates with R&D teams to develop test methods, ensuring they're ready for validation processes.Validates all test methods to meet...


  • Galway, Galway, Ireland beBeeCsvEngineer Full time €90,000 - €120,000

    Job Title: Csv EngineerWe are seeking a skilled expert to lead validation and assurance efforts across our clients' critical systems.As a key advisor to IT, Operations, and QA teams, you will ensure systems meet regulatory and quality standards (21 CFR Part 11, EU MDR, 21 CFR 820).This is a dynamic, hands-on role supporting both enterprise IT and operational...


  • Galway, Galway, Ireland beBeeValidation Full time €60,000 - €90,000

    Validation and Assurance ExpertWe are seeking a skilled Validation and Assurance professional to lead validation efforts across our clients' critical systems.This is a dynamic, hands-on role supporting both enterprise IT and operational technology environments.Lead validation and Computer Software Assurance (CSA) for IT and OT systemsDevelop and execute...


  • Galway, Galway, Ireland beBeeManufacturing Full time €75,100 - €104,110

    Job OverviewWe are seeking a highly skilled Senior Manufacturing Systems Specialist to join our team. The successful candidate will be responsible for the maintenance of our Manufacturing Execution System (MES) environment, authoring and maintaining recipes and worksheets for our manufacturing site using the POMSnet system.This role requires technical...