Description
Graduate Validation Engineer
Astellas Career Site: 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 meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. 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. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity. We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
The Opportunity:
As a Graduate Validation Engineer, you will be responsible for reviewing, developing, and controlling validation activities for all company projects, preparing validation documentation and reports, executing validation protocols, and working with personnel in implementing the validation lifecycle for projects. You will be part of an inclusive team that works to develop innovative therapies for patients.
Key Activities for this role:
1. Validation Scheduling
2. Evaluation of validation requirements.
3. Provide support to ensure that validation status reports are maintained.
4. Validation Standards
5. Familiarisation with developments and innovations in validation requirements.
6. Review/Implementation of procedures, reports, results etc. for compliance.
7. Validation Preparation Execution and Approvals
8. Execution of validation Protocols.
9. Provide input into the development of company validation standards.
Essential Knowledge & Experience:
1. Knowledge and understanding of Aseptic Manufacturing techniques.
2. Knowledge of ISPE baseline Guide for Commissioning and Qualification.
3. Understanding of pharmaceutical quality management systems, experience of various QMS tools such as Track Wise, Valgenesis, Vault.
4. Proficient knowledge and understanding of regional Good Manufacturing Practices for pharmaceutical products.
5. Actively participating in the investigation and resolution of quality events.
6. Conducting internal audits and supporting external regulatory inspections.
7. Reviewing and approving documentation related to manufacturing processes and quality systems.
8. Providing guidance and training to colleagues on quality-related matters.
9. Continuously monitoring and improving quality systems and processes.
Education/Qualifications:
1. Bachelor’s degree in engineering or equivalent.
Additional Information:
1. This is a permanent, full-time position.
2. This is located in our Irish office (Tralee Plan/County Kerry).
3. This position is field based in Tralee Plan/County Kerry/Ireland. Candidates must be located within a commutable distance of the office.
What We Offer:
1. A challenging and diversified job in an international setting.
2. Opportunity and support for continuous development.
3. Inspiring work climate.
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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