General Information
Job Advert Title Validation Engineer Location Ireland Function/Business Area Quality Employment Class PermanentDescription
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:
As a Validation Engineer, you are responsible 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. Your 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.
Key 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.
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