About Astellas
At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges, placing the patient at the heart of everything we do. Through our global vision for Patient Centricity, we integrate the patient experience into our everyday working practices. We have developed ground breaking medicines in immunology, oncology and urology, improving and saving the lives of patients worldwide. Learn more at Astellas.com
Are you driven to make a real difference in the lives of patients?
We are seeking individuals who thrive in dynamic environments, embrace new ideas and are committed to making a meaningful impact.
Location and Working Environment
This position is 100% onsite in Tralee, Ireland.
Purpose & Scope
• 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.
Role and 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.
Required Qualifications
• Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas.
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.
What awaits you at Astellas?
• Global collaboration and connection with like minded life science leaders.
• Real world patient impact through transformative therapies.
• Relentless innovation at the forefront of scientific advancement.
• A culture of growth that supports your development and ambitions.
Our Organizational Values and Behaviors
• Impact
• Innovation
• Integrity
• One Astellas
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus
Benefits
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.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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