Validation Engineer
1 week ago
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.
-
Graduate Validation Engineer
1 day ago
Ireland Astellas Ireland Full timeGraduate Validation Engineer About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or...
-
Graduate Validation Engineer
1 day ago
Ireland Astellas Ireland Full timeGraduate Validation Engineer About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or...
-
Validation Specialist
7 days ago
Ireland Haleon Full timeKey Responsibilities:Manages a team of Product and Process Engineers to support Product Lifecycle Management of products manufactured on site.Accountable for oversight, management, and delivery of all Validation Lifecycle components.Ensures compliance to evolving expectations of equipment and facility C&Q, process/packaging validation, cleaning validation,...
-
Validation Engineer
21 hours ago
Ireland Astellas Ireland Full time**Job Overview:**We are seeking a highly motivated and detail-oriented Graduate Validation Engineer to join our team at Astellas Ireland. As a member of our quality assurance department, you will be responsible for reviewing, developing, and controlling validation activities for all company projects.Responsibilities:**Preparing validation documentation and...
-
Validation Lead
4 weeks ago
Ireland Haleon Full timeHello. 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...
-
Senior Validation Specialist
1 day ago
Ireland Astellas Ireland Full time**Astellas Ireland: A Progressive Health Partner**We are a global biopharmaceutical company with a progressive approach to health. Our vision is to support the development of innovative health solutions through a deep understanding of the patient experience.**About This Opportunity**As a Graduate Validation Engineer, you will play a key role in reviewing,...
-
Validation Lifecycle Manager
17 hours ago
Ireland Astellas Ireland Full time**Job Description:**The Graduate Validation Engineer will be responsible for reviewing, developing, and controlling validation activities for all company projects. This includes preparing validation documentation and reports, executing validation protocols, and working with personnel to implement the validation lifecycle for projects.Key...
-
Astellas Ireland Validation Engineer Role
3 days ago
Ireland Astellas Ireland Full timeA New Opportunity at Astellas IrelandAt Astellas, we are committed to making treatments that truly matter to people. Our global vision for Patient Centricity drives us to develop innovative health solutions through a deep understanding of the patient experience.We believe all staff have a role to play in creating a patient-centric culture and integrating an...
-
Technical Lead
7 days ago
Ireland Haleon Full timeRequired Skills & Qualifications:BS degree in engineering, industrial pharmacy, chemistry, or other appropriate scientific or pharmaceutical discipline.Minimum of 5 years of demonstrated experience in a regulated Technical role, with strong experience in cleaning validation.Demonstrated experience in the FMCG or Pharmaceutical industry leading technical...
-
Quality Assurance Validation
1 week ago
Ireland Astellas Ireland Full timeQuality Assurance Validation 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....
-
Equipment Qualification Engineer
18 hours ago
Ireland Astellas Ireland Full timeThe RoleAs a Process Validation Manager, you will play a critical role in ensuring the quality and reliability of our processes. Your responsibilities will include:Developing and implementing process validation plans and schedulesCollaborating with cross-functional teams to design and execute validation activitiesAnalyzing data and reporting results to...
-
Process Engineer
1 week ago
Ireland ENG Bauen Ltd Full timeSenior Process Engineer | API Manufacturing Expansion ProjectCork, IrelandSite-BasedENG Bauen is supporting a leading global pharmaceutical company in delivering a major expansion project, requiring an experienced Process Engineer to oversee critical process evaluations within an API manufacturing environment. This is an opportunity to play a key role in a...
-
Engineering Project Manager
7 days ago
Ireland Astellas Ireland Full timeAbout Astellas Ireland">Astellas Ireland is an inspiring place to work, offering a chance to make a meaningful difference in the lives of patients. Our company culture is built on five core values: patient focus, ownership, results, openness, and integrity. We strive to create a patient-centric environment that fosters collaboration and ownership among our...
-
Graduate Pharmaceutical Engineer
7 days ago
Ireland Astellas Ireland Full timeAbout Astellas Ireland">Astellas Ireland is committed to delivering innovative therapies for patients. As a Graduate Engineer, you will contribute to this mission by supporting the execution of projects that adhere to Good Engineering Practices (GEP), regulatory requirements, and quality standards.">Job Description:">Your primary responsibility will be to...
-
Project Engineer
1 week ago
Ireland Astellas Ireland Full timeProject 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...
-
Project Engineer
2 weeks ago
Ireland Astellas Ireland Full timeProject 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...
-
Equipment Qualification Engineer
7 days ago
Ireland Astellas Ireland Full timeAstellas Ireland: A Leader in BiopharmaceuticalsWe have developed ground-breaking, innovative medicines in immunology, oncology, and urology, extending and saving the lives of cancer patients and improving the quality of life for those living with conditions where needs are often overlooked.The Job DescriptionThis role involves responsibility for preparing...
-
Graduate Engineer
1 week ago
Ireland Astellas Ireland Full timeGraduate 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...
-
Graduate Engineer
7 days ago
Ireland Astellas Ireland Full timeGraduate 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...
-
Pharmaceutical Process Development Engineer
7 days ago
Ireland Astellas Ireland Full timeAbout Astellas Ireland">Astellas Ireland is a global pharma company with a commitment to making a meaningful difference in the lives of patients. As a Graduate Engineer, you will play a key role in supporting the execution of projects that adhere to Good Engineering Practices (GEP), regulatory requirements, and quality standards.">Job Description:">You will...