Title: Technical Associate
IE
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
- This position is based in Tralee, Ireland.
- This position requires you to be 100% on site / in the office.
Purpose and Scope
Responsible for performing preventive, predictive, and corrective maintenance on equipment, utilities, and facility systems within an aseptic fill-finish pharmaceutical manufacturing facility. Ensures reliable operation in compliance with all regulatory, legislative, and statutory requirements while working in classified cleanrooms (ISO 5–8). Supports the Team Lead, contributes to manufacturing projects and site initiatives, and actively participates in the site’s Operational Excellence Programme.
Role and Responsibilities
- Equipment Maintenance & Troubleshooting: Perform preventive, predictive, and corrective maintenance on aseptic fill-finish equipment, including filling lines, lyophilizers, capping, inspection, packaging, autoclaves, and associated systems.
- Facility & Utilities Support: Maintain and troubleshoot critical utilities and facility systems, including clean steam, WFI, compressed gases, HVAC, environmental monitoring, and room condition systems.
- GMP, Compliance & Documentation: Complete maintenance records, work orders, deviations, and system data accurately, ensuring compliance with cGMP, GDP, site standards, and data integrity requirements.
- Safety, Quality & Continuous Improvement: Promote safe working practices, support investigations and problem-solving, improve equipment reliability, reduce downtime, and contribute to operational excellence and process improvements.
- Projects & Technical Support: Support equipment qualification, validation, change controls, engineering projects, new product and technology introductions, and development of technical solutions and processes.
- Teamwork, Training & Reporting: Work collaboratively across functions, complete required training, contribute to documentation and knowledge sharing, report issues promptly to the Team Lead, and support a strong culture of safety and teamwork.
Essential Qualifications
- Minimum Level 6 Technical qualification or certification in mechanical, electrical, automation or industrial maintenance required.
Preferred Qualifications
- Technical & GMP Experience: Experience in cGMP pharmaceutical, biotech, or aseptic fill-finish environments, with knowledge of automated equipment, PLCs, cleanroom systems, HVAC/utilities, computerised systems, audits, and regulatory requirements.
- Communication & Teamwork: Excellent organisational, interpersonal, verbal, and written communication skills, with the ability to work independently or collaboratively and adapt effectively to changing priorities.
- Problem Solving & Continuous Improvement: Strong analytical and problem-solving abilities, with a commitment to continuous improvement and Lean Six Sigma principles (Yellow Belt or higher advantageous).
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
Skills and Capabilities
Benefits
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.
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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