Description
Lyophilisation Lead 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
The role provides technical support to the Operations Department by conducting effective investigations, root cause analysis, and implementing corrective actions to ensure efficient lyophilisation operations and adherence to manufacturing schedules. It ensures full compliance with internal and external regulatory, legislative, and statutory requirements, while delivering strategic, value-adding operational input to support the plant's technical lyophilisation activities, projects, and initiatives. Acting as the lyophilisation process expert, the role supports the Operations Lead, follows assigned direction, and actively embeds the site's Operational Excellence Programme across all operations. Responsibilities also include training and developing staff, preparing and maintaining production SOPs and related documentation, completing required LMS training, and promoting strong teamwork and a culture of safety awareness. The role ensures compliance with cGMP, ISO 14001, EMAS, Health & Safety, and Environmental legislation, supports cross-functional compliance efforts, operates equipment as required to support lyophilisation operations, and undertakes additional duties as directed by the Operations Lead.
Responsibilities
* Provide technical support to lyophilisation operations, engineering, and control systems to ensure efficient, compliant operations and achievement of production and project schedules.
* Ensure GMP compliance and data integrity of computerised systems within remit, maintaining high system performance in line with site standards and regulatory expectations (FDA, EMA, ICH).
* Lead and support incident, deviation, and CAPA activities through effective investigation, root cause analysis, and timely implementation of corrective actions.
* Drive proactive problem solving, process optimisation, and continuous improvement initiatives using Lean Six Sigma, delivering measurable performance, cost, energy, and waste reduction benefits.
* Manage and contribute to projects, technology transfer, and commissioning activities, providing process engineering expertise and leading or supporting cross-functional teams.
* Apply strong analytical, prioritisation, and project execution skills, with experience in PAT, automation, SCADA/HMI, and cycle modelling, while remaining adaptable to changing operational needs.
Preferred Knowledge & Experience
* Experience in freeze-drying/lyophilisation process development or operations in pharma/biotech. (e.g., Lyomax).
* Experience in a cGMP start up environment is preferred along with advanced technical technical experience including: expert knowledge relating to Aseptic vial Lyophilisation process, including CIP, SIP & FIT. Experienced with process control systems, process instrumentation, equipment qualification, and process validation.
* Possesses excellent organisational, interpersonal, verbal communication and written communication skills.
* Ability to work effectively using own initiative or as a member of a team as required.
Education
* Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Sciences, Bioprocess Engineering, Biotechnology, or related field, or significant relevant experience.
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.
* Willingness to undertake international travel.
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.
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