Description Senior Process Engineer About Astellas: 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: You will provide technical support to the Operations Department, including conducting effective investigations and root cause analyses, as well as implementing corrective actions to ensure efficient production operations and support adherence to the manufacturing schedule.
You'll ensure compliance with all internal and external regulatory, legislative, and statutory requirements within the Operations function.
You will also offer strategic value-add operational input and direction in support of the plant's technical operational activities and requirements, including assisting with projects and initiatives in the manufacturing areas.
You'll support the Operations Engineering Lead by providing operational expertise across all relevant areas and follow their direction in executing the duties assigned to you.
Additionally, you will become a process expert on Aseptic Filling and Lyophilisation, and actively support the site's Operational Excellence Programme, ensuring it is fully embedded in all aspects of production operations.
Key Responsibilities: Provide technical support to operational areas and engineering personnel to ensure efficient operations and meet production/project schedules.
Manage DCS and control systems, ensuring compliance with site standards and maintaining system performance.
Ensure the integrity of data in GMP computerised systems through proper administration and compliance.
Lead incident and deviation investigations, resolving issues promptly and expediting CAPA implementation.
Drive proactive problem-solving, resolve equipment issues, and implement short- and long-term solutions.
Support projects, continuous improvement activities (including Lean Six Sigma), technology transfers, and staff training, promoting safety, teamwork, and regulatory compliance.
Essential Knowledge & Experience: Experience in a cGMP start-up environment with technical proficiency in filtration, purification, process control systems, equipment qualification, and process validation.
Strong organisational, interpersonal, and communication skills, with the ability to work independently or within a team.
Capable of prioritising multiple commitments and projects, adapting to changing department/facility needs, and providing engineering design and commissioning services.
Proven analytical, problem-solving skills, Lean Six Sigma (Yellow Belt) proficiency, and experience with control systems (DCS, PLC).
Education: B.S.
in Engineering, Chemical / Biochemical discipline or equivalent, or extensive related proven experience in the required areas; or equivalent.
Additional information:This is a permanent, full-time position Position is based in Tralee – Ireland.
This position requires you to be 100% on-site/in the office.
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.