IT System Validator

1 week ago

Cork, Cork, Ireland beBeeSoftware Full time €60,000 - €80,000

System Validation Role

We are seeking a skilled IT system validation specialist to work within the pharmaceutical sector. This role is critical in ensuring that all systems and software comply with regulatory standards, operational requirements, and industry best practices.

  • The incumbent will be responsible for managing the qualification of IT systems, including hardware, software, and infrastructure within a GMP lab setting.
  • He/she will validate software applications used in manufacturing, quality control, and other pharmaceutical processes.
  • Collaboration with software vendors will ensure system validation documentation is complete and accurate.
  • Additionally, the person will manage the lifecycle of validated software, including upgrades and decommissioning.
  • Periodic reviews of validated systems will ensure continued compliance.
  • Traceability matrices will be developed and maintained to ensure alignment with user requirements.
  • Validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), will be developed and executed.
  • Documentation, such as validation plans, reports, and risk assessments, will be authored, reviewed, and approved.
  • All validation activities will comply with regulatory standards like Gx P, FDA 21 CFR Part 11, and EMA guidelines.
ResponsibilitiesKey Skills:
  • A bachelor's degree in computer science, information technology, or a related field.
  • At least three years of experience in IT system validation, preferably in a pharmaceutical or regulated environment.
  • Thorough knowledge of Gx P regulations, FDA 21 CFR Part 11, and other relevant standards.
  • Experience in validating ERP, LIMS, MES, and other pharma-specific IT systems.
  • Strong understanding of software development lifecycle (SDLC) and validation best practices.
  • Familiarity with IT infrastructure, database management, and networking in a validated environment.
  • Excellent problem-solving, analytical, and organizational skills.
  • Strong written and verbal communication skills, with the ability to present results to diverse audiences.
Benefits

This role offers the opportunity to work in a dynamic pharmaceutical environment and contribute to ensuring the quality and integrity of our products.

  • IT System Validator

    1 week ago

    Cork, Cork, Ireland beBeeValidation Full time €60,000 - €80,000

    Job Title: IT Validation SpecialistCatalyx is seeking a skilled professional to join their team and work on site in Cork. This role focuses on validating IT systems to ensure regulatory compliance, operational requirements, and industry best practices within a pharmaceutical or highly regulated environment.Key Responsibilities:Manage the qualification of IT...

  • System Validator

    2 weeks ago

    Cork, Cork, Ireland beBeeValidation Full time €60,000 - €80,000

    Job Title: System ValidatorCognizant is seeking a highly skilled and experienced System Validator to join our team on a long-term basis.This full-time role involves collaborating with cross-functional teams to ensure the validation of laboratory systems in QCL Labs and Manufacturing Operations.As a System Validator, you will be responsible for providing...

  • System Validation Specialist

    2 days ago

    Cork, Cork, Ireland beBeeDataValidationEngineer Full time €75,000 - €105,000

    Job OpportunityWe are seeking skilled professionals to join our team in a Data Validation Engineer role. This position will play a critical part in ensuring the accuracy, quality, and compliance of data across validated IT systems.The successful candidate will be responsible for developing and executing data/system validation plans across IT platforms,...

  • Senior It Systems Validator

    5 days ago

    Cork, Cork, Ireland beBeeItValidation Full time €70,000 - €100,000

    IT Validation ExpertThe role of IT validation expert is critical in ensuring compliance with regulatory standards, operational requirements, and industry best practices.Key Responsibilities:Manage the qualification of IT systems, including hardware, software, and infrastructure within a regulated environment.Validate software applications used in...

  • System Validation Analyst

    3 weeks ago

    Cork, Cork, Ireland Oxford Global Resources Full time

    Social network you want to login/join with:Are you a systems validation analyst based in Ireland looking for a new opportunity?Don't hesitate and apply todayThe successful candidate will support validation activities in respect to CSV and CSA activities.Proven expertise in designing, developing and executing text plans and strategies as well as the...

  • System Validation Specialist

    1 week ago

    Cork, Cork, Ireland beBeeValidation Full time €55,000 - €75,000

    Job Title: System Validation SpecialistWe are seeking a skilled System Validation Specialist to join our team.About the Role:The successful candidate will be responsible for managing lab system validation projects from installation to business release, ensuring seamless integration and compliance with regulatory requirements.Prioritizing tasks in line with...

  • System Validation Professional

    2 days ago

    Cork, Cork, Ireland beBeeDataIntegration Full time €80,000 - €100,000

    Job Title: Data Integration SpecialistKey Responsibilities:Manage validation projects for computerized systems from installation to business release.Prioritize tasks in line with project timelines and monitor progress.Develop and review validation documentation, including design specs, configuration specs, testing plans, security protocols, and test summary...

  • Computer Systems Validation Expert

    1 day ago

    Cork, Cork, Ireland beBeeValidation Full time €60,000 - €80,000

    System Validation SpecialistA skilled System Validation Specialist is required to ensure the validation of computerised equipment and systems in a pharmaceutical manufacturing environment. The successful candidate will have experience with CSV validation and be able to work on site with occasional remote working.Key Responsibilities:Validate new computerised...

  • Computer System Validation Specialist

    6 days ago

    Cork, Cork, Ireland beBeeValidation Full time €60,000 - €85,000

    Job Title: Computer System Validation SpecialistThe role of a Computer System Validation Specialist is to ensure that all computerized equipment and control systems in the manufacturing environment are validated according to regulatory requirements.This involves generating validation documentation, executing protocols, participating in change control...

  • Csv System Validation Specialist

    5 days ago

    Cork, Cork, Ireland beBeeValidator Full time €63,000 - €90,693

    Csv Engineer Job OpportunityAs a Csv Engineer, you will play a vital role in validating lab systems and ensuring compliance with regulatory requirements. This position offers a unique blend of technical expertise and business acumen, making it an attractive career path for professionals seeking to grow and develop their skills.Main Responsibilities:Validate...