▷ [1/8/2025 A] Sr QA Validation Specialist (IT Infrastructure)

21 hours ago


Limerick, Ireland Regeneron Pharmaceuticals, Inc Full time

The individual in this position implements policies and procedures to qualify IT infrastructure platforms and validate computer systems. Plans, coordinates, and participates in a compliant qualification process for qualifying information technology infrastructure platforms which requires formal qualification documentation under appropriate regulatory requirements and company standards.

As a Sr QA Validation Specialist (IT Infrastructure) typical day might include, but is not limited to, the following:

- Analysing the results of testing and determines the acceptability of results against predetermined criteria

- Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements

- Identifying current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation vital to ensure compliance within the operation

- Leading process improvement projects to improve the qualification of infrastructure platforms

- Coordinating with other departments or outside contractors/vendors to complete validation tasks

- Participating in regulatory audits and communicates company’s computer validation policies

- Assessing company’s infrastructure platforms and identifies any potential security gaps and ensure the best data integrity practices are implemented

- Training Specialists and Technicians

- Technical writing experience

- Generating, reviewing, and approving of qualification/validation documents

- Completing risk assessments in relation to IT infrastructure activities

- Advising and supporting all teams on IT infrastructure and computer systems qualification activities

This position might be for you if:

- You have experience with principles of infrastructure and VMware in the Private & Hybrid Cloud domain, as well as an understanding of network infrastructure devices, firewalls and active directory administration

- You have solid understanding and experience with Computer Systems Validation and/or IT Auditing

- You have an understanding of the interdependencies of change management, deviation and continuous improvement

- You have the ability to work in a dynamic organization where innovative solutions are required to ensure a high-level of quality is achieved within required timelines

- You possess a thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211

To be considered for this position you must hold a Bachelor's degree in Computer Science, Information Systems, or a related field with at least 5+ years of experience in IT CSV engineering or a related field.

#J-18808-Ljbffr



  • Limerick, Ireland Regeneron Ireland DAC Full time

    The individual in this position implements policies and procedures to qualify IT infrastructure platforms and validate computer systems. Plans, coordinates, and participates in a compliant qualification process for qualifying information technology infrastructure platforms which requires formal qualification documentation under appropriate regulatory...


  • Limerick, Ireland Regeneron Pharmaceuticals, Inc Full time

    Within this role you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with...

  • Validation Specialist

    7 hours ago


    Limerick, Ireland Life Science Recruitment Full time

    We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties 1. Execute cycle development, cleaning validation and PQ of equipment. 2. Writing and adhering to...


  • Limerick, Ireland Regeneron Ireland DAC Full time

    The Manager QA Validation is responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regeneron's Raheen facility. A typical day might include, but is not limited to, the following: Designing and developing policies for validation and ensuring that they are effectively administered and comply...


  • Limerick, Ireland Regeneron Ireland DAC Full time

    Within this role you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with...

  • QA Robotics Engineer

    2 hours ago


    Limerick, Ireland Analog Devices, Inc. Full time

    Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably...


  • Limerick, Ireland SOLAS IT RECRUITMENT Full time

    Automation QA We are seeking a skilled Automation QA Engineer to join our dynamic team. The ideal candidate will have experience in API testing, proficiency in automation tools such as Selenium and SpecFlow, and a solid background in Agile environments. If you have strong skills in C# or Java and a passion for delivering high-quality software, we want to...


  • Limerick, Ireland QA Resources Full time

    Senior Regulatory Officer Industry: Medical Device Department: Regulatory Affairs Role Summary – Major Activities: 1. Provide coaching and support to all employees on the regulatory team. 2. Ensure employees understand their duties/delegated tasks. 3. Prepare and maintain IVDR compliant technical files utilising information from cross functional...

  • Marketing Specialist

    13 hours ago


    Limerick, Ireland Fleming Medical Ltd Full time

    Marketing Specialist – Medical Equipment At Fleming Medical, we are committed to advancing healthcare through innovative medical equipment and technology solutions. Our team is passionate about improving patient outcomes and empowering healthcare professionals with our range of products. We are looking for a dynamic and experienced Marketing Specialist to...


  • Limerick, Ireland FRS Recruitment Full time

    Perfect QA role for a self-starter with a strong background in Quality Assurance and GMP In this key QA position, you'll take ownership of Quality Assurance activities to ensure biological products are manufactured in strict compliance with GMP and regulatory standards. You'll collaborate across departments, manage critical QMS responsibilities, and...


  • Limerick, Ireland FRS Recruitment Full time

    Perfect QA role for a self-starter with a strong background in Quality Assurance and GMP In this key QA position, you’ll take ownership of Quality Assurance activities to ensure biological products are manufactured in strict compliance with GMP and regulatory standards. You’ll collaborate across departments, manage critical QMS responsibilities, and...


  • Limerick, Ireland FRS Recruitment Full time

    Perfect QA role for a self-starter with a strong background in Quality Assurance and GMP In this key QA position, you'll take ownership of Quality Assurance activities to ensure biological products are manufactured in strict compliance with GMP and regulatory standards. You'll collaborate across departments, manage critical QMS responsibilities, and...

  • Technical Writer

    21 hours ago


    Limerick, Ireland PSC Biotech Full time

    Technical Writer - Cleaning Validation SIP Limerick, Ireland | Posted on 11/12/2024 - Industry: Pharma/Biotech/Clinical Research - Work Experience: 2-3 years - City: Limerick - State/Province: Limerick - Country: Ireland Job Description About PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona,...


  • Limerick, Ireland Cook Medical Full time

    Overview The Senior Manufacturing Engineer (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulataory standards. Validate and implement medical device manufacturing processes as assigned. Identify equipment/fixture installation...


  • Limerick, Ireland Regeneron Ireland DAC Full time

    The Director/Sr Director EHS & Security will be responsible for the oversight of all Health, Safety, Environmental and Security operations to comply with or exceed local and national environmental regulatory compliance for IOPS (Industrial Operations & Product Supply) division of Regeneron in Limerick. As the Director/Sr Director EHS & Security, a typical...


  • Limerick, Ireland Merck Gruppe Full time

    Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...


  • Limerick, Ireland Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Civil Engineer

    2 hours ago


    Limerick, Ireland Global Professional Consultants Full time

    Civil Engineer (Infrastructure) Civil Engineer with 5+ years experience required to join an Irish-owned multidisciplinary engineering consultancy that has been operating for over 70 years in Limerick. The successful Civil Engineer will be responsible for the civil infrastructure design and management of a range of projects including sports, educational,...


  • Limerick, Ireland Northern Trust Full time

    About Northern Trust: Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring...


  • Limerick, Ireland RedChair Recruitment Full time

    Our client is seeking a highly motivated and customer-focused individual to join their team as a Level 1 Technical Support Specialist. The ideal candidate will possess excellent communication skills, a strong technical aptitude, and a passion for helping others resolve technical issues. As a Level 1 Technical Support Specialist, you will be the first point...