Senior Process Engineer
About Astellas:
Astellas is an inspiring place to work, offering a chance to make your mark and do good for others.
Our expertise, science, and technology make us a pharmaceutical company with a strong focus on patient-centricity.
We have a progressive culture that drives us to contribute to a sustainable society and deliver meaningful differences for patients.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience.
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.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus, ownership, results, openness, and integrity.
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.