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:
The individual is responsible for performing preventive, predictive, and corrective maintenance on equipment and systems within an aseptic fill-finish pharmaceutical manufacturing facility, ensuring timely execution while working in classified cleanrooms (ISO 5–8) with appropriate gowning. They ensure the reliable operation of production equipment, utilities, and facility systems to support aseptic manufacturing in full compliance with all internal policies and external regulatory, legislative, and statutory requirements. The individual takes direction from the Team Lead and supports the execution of assigned duties, while also contributing value-added input to support plant operations, including involvement in projects and initiatives within manufacturing areas. Additionally, they actively participate in the site's Operational Excellence Programme.
Responsibilities:
- Equipment Maintenance & Troubleshooting
- Perform routine, preventive, and emergency maintenance on aseptic fill-finish equipment (e.g., compounding systems, filling lines, lyophilizers, cappers, inspection/packaging equipment, washers, autoclaves). Troubleshoot mechanical, electrical, pneumatic, and control issues to minimize downtime while adhering to GMP, GDP, and safety standards.
- Facility & Utility Systems Support
- Maintain and support critical utilities such as WFI, clean steam, compressed gases, HVAC, and environmental/room monitoring systems essential for aseptic operations.
- Compliance, Documentation & Data Integrity
- Complete CMMS entries, maintenance logs, deviations, and documentation in compliance with cGMP and GDP. Ensure data integrity across computerized systems and participate in investigations as needed.
- Safety, Quality & Continuous Improvement
- Ensure compliance with cGMP, ISO 14001, health, safety, and environmental standards. Contribute to problem-solving, equipment reliability, process improvements, and validation/engineering projects while fostering a culture of safety and teamwork.
- Projects, Change Controls & New Technologies
- Support operational projects, change controls, and equipment qualification (IQ/OQ/PQ). Assist with the introduction of new products, processes, and technologies, continuously seeking efficiency and innovation.
- Training, Communication & Reporting
- Complete all required training (OTJ/LMS), deliver training when needed, and engage in technical documentation updates. Provide timely feedback to the Team Lead, participate in meetings, and support effective cross-functional communication.
Education:
- Level 6 qualification in Mechanical/Electrical/Automation/Industrial maintenance or equivalent required
- Preferred Experience:
- Industry & Technical Experience
- Experience in cGMP environments within pharmaceutical, biotech, or aseptic fill-finish manufacturing is an advantage, including familiarity with automated equipment, PLCs, HVAC, cleanroom systems, utilities, audits, and regulatory guidance.
Skills & Competencies:
- Strong organisational, interpersonal, verbal, and written communication skills. Demonstrated ability to work independently or in a team, adapt to changing priorities, and contribute to a culture of continuous improvement.
- Analytical & Problem-Solving Abilities
- Proven analytical thinking and problem-solving skills, with Lean Six Sigma (Yellow Belt or higher) considered an advantage.
Additional information:
- Position is based in Tralee
- This position is 100% on-site
- Willingness to undertake international travel to vendor sites occasionally
What We Offer:
A challenging and diversified job in an international setting.
Opportunity and support for continuous development.
Inspiring work climate.
The position is based in Tralee - Ireland
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.
#LI-Tralee
#LI-Onsite
#LI-LL1