Quality Engineer (IE)

Biopharma Careers; Ireland; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Hybrid work

On-site role in Tralee

Job summary

Astellas is seeking a Quality Engineer for its on-site role in Tralee, Ireland. The role focuses on ensuring GMP/GDP compliance for an aseptic fill-finish facility, collaborating with Validation, Engineering, Facilities, QC, and QA regulatory teams.

Hybrid working options are available to balance office and home working. The candidate will develop procedures, perform risk assessments, prepare regulatory submissions, and support audits while driving continuous quality improvement.

Qualifications

• Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas.

Responsibilities

• Ensure compliance with internal/external regulatory, legislative, and statutory requirements, promoting awareness across Operations.
• Develop operational procedures for best practice and regulatory compliance; conduct risk assessments on processes and equipment.
• Generate reports and data for Annual Product Quality Reviews, Regulatory submissions, customer complaint investigations, and periodic reviews.
• Support internal/external audits, ensuring timely issue resolution, and raise/review non-conformances.
• Provide quality technical support to Operations, including investigations, root cause analysis, and corrective actions to support production and schedule adherence.
• Support plant operational activities, Change Control, commissioning/qualification, and work closely with QA regulatory departments for submissions.

Skills

Quality Assurance

GMP/GDP

Regulatory compliance

Risk assessment

Data analysis

Education

Engineering or Science degree

Job description

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Working Environment and Location

Position is based in Tralee - Ireland

This position requires you to be 100% on site / in the office

Willing to work additional hours and/or travel as required by the business.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Purpose and Scope

The role of the Quality Engineer will be to support the operations department to ensure compliance with GMP/GDP requirements for an Aseptic fill finish facility. Responsibilities include ensuring adherence to regulations and guidance, industry best practices, internal policies and procedures. This position works closely with Validation, Engineering, Facilities, Quality Control (QC) and other supporting functions to ensure compliance.

Role and Responsibilities

• Ensure compliance with internal/external regulatory, legislative, and statutory requirements, promoting awareness across Operations.
• Develop operational procedures for best practice and regulatory compliance; conduct risk assessments on processes and equipment.
• Generate reports and data for Annual Product Quality Reviews, Regulatory submissions, customer complaint investigations, and periodic reviews.
• Support internal/external audits, ensuring timely issue resolution, and raise/review non-conformances.
• Provide quality technical support to Operations, including investigations, root cause analysis, and corrective actions to support production and schedule adherence.
• Support plant operational activities, Change Control, commissioning/qualification, and work closely with QA regulatory departments for submissions.

Essential Qualifications

Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas.

Benefits

Careers | Astellas

Why Astellas

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organisational Values and Behaviours

• Integrity
• Innovation
• Impact
• One Astellas
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus

Skills and Capabilities

Organizational Focus

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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