About This Job Provision of technical support to the operational areas and engineering personnel in order that operations are conducted efficiently, and approved production and project schedules are achieved.Responsible for the DCS and other control systems in operational areas.
Ensuring system compliance with all site standards and procedures.
This includes maintaining a high level of system operational performance.Responsible for ensuring that the administration of GMP computerised systems in your remit is carried out in a manner which ensures the integrity of the data created, modified, or maintained on the systems.Lead proactive problem-solving efforts and resolves process equipment issues, diagnoses technical problems, and determines short-term and long-term solutions.Responsible for expediting CAPA implementation pertaining to Operations Department raised incidents/deviations in line with target completion dates.Manage and/or support activities to maximise value (e.g., increase revenue, reduce costs) such as (but not limited to) process optimisation, waste reduction/recycling, energy saving etc.Co-ordinate continuous improvement activities in the area through the application of Lean Six Sigma.
Lead CI forums to identify and review the progress of improvement initiatives to ensure benefits are realised.
Report on area performance.Manage and/or support technology transfer for new technologies and processes, as required.Complete assigned LMS training items in line with target completion dates.Ensure compliance with relevant regulations and standards associated with cGMP, ISO 14001, EMAS, Health & Safety Legislation and Environmental Legislation, and all site standards, policies, and procedures.
Support other sections to ensure such compliance.Essential Knowledge & ExperienceMinimum requirement: B.S.
in Engineering, Chemical / Biochemical discipline or equivalent experience.Industry experience of successful delivery, preferably in a similar role.Technical proficiency, including broad understanding of filtration and purification technologies and processes, experience with process control systems, process instrumentation, equipment qualification, and process validation.Able to demonstrate previous experience of successfully progress projects independently, provide process engineering design, implementation/commissioning services and maintenance support of cGMP manufacturing.Able to demonstrate significant contributions on project.Proven analytical and problem-solving skills including Lean Six Sigma proficiency to at least Yellow Belt level.Preferred Knowledge & ExperienceDirect experience in drug manufacturing.Experience in a cGMP start up environment.Experience of control systems (DCS, PLC) would be an advantage.Additional information20% travel (domestic and International)This is a permanent role.Based at manufacturing plant Tralee.This role is onsite.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.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.