Description
Process Engineer
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
Reporting directly to the Operations Engineering Lead, you will provide technical support to the Operations Department, including effective investigation and root cause analysis, as well as the implementation of corrective actions to ensure efficient production operations and support manufacturing schedule adherence. You will also be responsible for ensuring that all of the above functions comply with internal and external regulatory, legislative, and statutory requirements.
Responsibility
* 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.
Education
* Minimum requirement: B.S. in Engineering, Chemical / Biochemical discipline or equivalent experience.
Essential Knowledge & 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 & Experience
* Direct experience in drug manufacturing.
* Experience in a cGMP start up environment.
* Experience of control systems (DCS, PLC) would be an advantage.
Additional Information
* This role requires approximately 20% travel, both domestic and international.
* This is a permanent, full-time position.
* This position is based at the manufacturing plant in Tralee, Ireland.
* This position requires you to be 100% on-site.
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.