Validation Engineer

3 weeks ago

Ireland Astellas Ireland Full time

Validation Engineer About Astellas At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges putting the patient at the heart of every move we make. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked. We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives. From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners. The Opportunity This position involves responsibility for preparing and executing the validation activities, compliance of the plant, requires decision-making, and contributing to planning within the validation department. It involves ensuring that all validation activities are carried out to the highest standard in compliance with all relevant regulations, standards, and guidance. The position will contribute to planning and execution of the validation activities as they are required in an aseptic fill finish facility. The position holder is capable of understanding technology and equipment such that they can complete the required validation activities. Responsibilities Validation Scheduling: Assess validation requirements (new equipment, change controls, etc.), monitor project status, and ensure timely updates. Status Reports & Support: Maintain validation status through monthly reports and meetings, collaborating with project managers to adhere to schedules. Validation Standards: Ensure cGMP compliance, stay updated on validation innovations, and implement global and AICL, CSV documentation and procedures. Validation Execution & Approvals: Execute and approve validation protocols, review project change controls, and prepare necessary documentation and reports. General Responsibilities: Contribute to developing company validation standards and assist with department growth as needed. Regulatory & Audit Support: Present professionally to management and auditors, support SLC processes, and address queries during partner or regulatory inspections. Essential Knowledge & Experience Clear Communication & Justification: Effectively communicate and justify validation positions in SDLC discussions, applying relevant regulatory and industry knowledge. Logical Decision-Making: Approach topics logically, considering multiple perspectives and making informed decisions based on experience and expertise. Global Collaboration & Project Management: Work with global stakeholders, manage local validation projects, and contribute to larger cross-functional projects as a representative of the Validation team. Education Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas. Additional information This is a permanent full-time position Position is based in Tralee - Ireland This position requires you to be 100% on site / in the office We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.

  • Validation Lead

    2 weeks ago

    Ireland Haleon Full time

    Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep human...

  • Validation Specialist

    4 weeks ago

    ireland TN Ireland Full time

    Social network you want to login/join with:Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI.Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.Main...

  • Automation Validation Engineer

    4 weeks ago

    newtown, the municipal district of borris-in-ossory — mountmellick, ireland Xyntek Inc. Full time

    Newtown, United States | Posted on 05/28/2024Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was...

  • Senior Validation

    4 weeks ago

    clare, claremorris-swinford municipal district, ireland Beckman Coulter Instruments Full time

    Wondering what's within Beckman Coulter Diagnostics? Take a closer look.At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds,...

  • Quality Lead, Validation

    4 weeks ago

    ireland TN Ireland Full time

    Social network you want to login/join with:Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI.Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.We are...

  • Validation Specialist

    4 weeks ago

    damastown, county dublin, ireland Viatris Full time

    At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access – Providing high quality trusted medicines regardless of geography or...

  • QA Validation Specialist

    4 weeks ago

    clare, claremorris-swinford municipal district, ireland Meiragtx Ireland DAC Full time

    Your missionTo provide QA Validation and Qualification technical support and oversight for the manufacture and supply of Gene Therapy medicinal products. The QA Validation Specialist will play a key role as part of the MGTX Ireland Project team providing hands-on QA technical support and oversight to Qualification and Validation activities of the...

  • Automation Project Engineer

    4 weeks ago

    ireland Process Automation – Controls.Instruments.Validations, Inc. Full time

    Position: Automation Project EngineerLocation: Dublin, IrelandPACIV, a global leader in industrial automation solutions with offices in Ireland, the United States, and Puerto Rico, serving the Life Science, F&B, and Utilities industries, is looking for an Automation Project Engineer. This is a site-based role.Job DescriptionThis role is an Automation Project...

  • Senior Validation

    4 weeks ago

    clare, claremorris-swinford municipal district, ireland Beckman Coulter Instruments Full time

    Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates...

  • Jr/Mid Level Process Engineer

    4 weeks ago

    ireland Quanta Consultancy Services Ltd Full time

    Jr/Mid Level Process Engineer - Ireland - 12 Months ContractDo you want to be involved with exciting pharmaceutical projects?When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add...

  • Manufacturing Engineer

    1 day ago

    Ireland Astellas Ireland Full time

    Manufacturing Engineer About Astellas At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others. Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing good for others and contributing to a sustainable society....

  • C++ Software Engineer

    4 weeks ago

    ireland YO IT CONSULTING Full time

    This range is provided by YO IT CONSULTING. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range$20.00/hr - $27.00/hrC/C++ DeveloperExperience: 6 - 20 YearsOpportunity: Full Time, 8 hours, 4 hours Mandatory overlap with PSTContract length: 6 MonthsTotal Years Of exp: 6+ years MandatoryMandatory...

  • Project Manager CQV Engineer

    3 days ago

    Ireland Commissioning Agents Inc (CAI) Full time

    Project Manager Quality Control/Validation Ireland / North Europe / Full-Time About CAI: CAI is a 100% employee-owned company established in 1996, growing year over year to nearly 700 employees worldwide. We provide commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness in...

  • Field Service Engineer

    23 hours ago

    ireland CMS Full time

    Job Details SSR is currently looking for experienced Field Engineer's to cover areas in Surrey & Kent. • A competitive salary • Potential for career development • days leave (includes public/bank holidays), • Death in Service Scheme ( x basic salary) • Employee Assistant Program • Private Health Care There will be out-of-hours...

  • QC Instrumentation Engineer

    4 weeks ago

    ireland Hobson Prior Full time

    Hobson Prior is seeking a QC Instrumentation Engineer to join the team. This role will help manage and maintain laboratory equipment, ensuring everything runs smoothly and meets quality standards. The successful candidate will also work on integrating systems to make the lab more efficient and paperless.Please note that to be considered for this role you...

  • Assistant Engineer NRO

    4 weeks ago

    ireland Localgov Full time

    The CandidateIt is desirable that candidates demonstrate through their application form and at the interview that they have the following essential experience and skills:Possess excellent professional/technical knowledge and skillsProven ability to deliver quality work and servicesExcellent communication and interpersonal skillsHave satisfactory experience...

  • Senior Embedded Test Engineer

    4 weeks ago

    ireland Chipright Full time

    You will work in the Test team and be responsible for test content development, automation, and commercialization of key software drivers. You will work with technologies including USB, PMIC, PCIe, Hypervisor, Boot, Clocks, and Storage. This role will involve balancing some hands-on testing and leveraging that knowledge to build sophisticated automated test...

  • Quality Engineer

    5 days ago

    Ireland Astellas Ireland Full time

    Quality Engineer About Astellas: At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges putting the patient at the heart of every move we make. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At...

  • Systems Engineer

    3 days ago

    Ireland Astellas Ireland Full time

    Systems Engineer About Astellas At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others. Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing good for others and contributing to a sustainable society. Delivering...

  • Facilities Engineer

    2 weeks ago

    Ireland Astellas Ireland Full time

    Facilities Engineer About Astellas: At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others. Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing good for others and contributing to a sustainable society....