Global Quality Control Labs Associate Application Engineer, Manufacturing Systems
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:
Astellas is seeking a Global QC Labs Application Engineer to serve as a Subject Matter Expert in the administration, maintenance, and enhancement of laboratory systems. In this role, you will be involved in managing and optimizing GxP and non-GxP systems, such as Chromatography Data Systems (CDS), Scientific Data Management Systems (SDMS), Laboratory Information Management Systems (LIMS), and Electronic Lab Notebooks (ELN), within a complex Scientific IT environment to support Manufacturing QC labs.
Key Activities for this role:
- Serve as the first point of contact for QC labs, providing technical support and issue resolution for lab systems.
- Administer, maintain, and manage user access for systems like LIMS, Empower, NuGenesis, ELN, and Binocs.
- Facilitate system enhancements, collaborating with vendors and ensuring seamless system integration with business systems.
- Act as a subject-matter expert during audits and conduct user training for proper system usage.
- Monitor system performance, optimize efficiency, and contribute to process improvements within the Scientific IT landscape.
Essential Knowledge & Experience:
- Proven experience in scientific IT, preferably in pharma/biotech.
- Expertise in CDS, LIMS, SDMS lab systems, and knowledge of manufacturing processes and Computer System Validation (CSV) according to GAMP 5 principles.
- Strong analytical, problem-solving, and communication skills (English for QC Labs and Site management).
- Experience in defining user stories, conducting impact analysis, supporting technical upgrades, and managing audits.
- Ability to work collaboratively in teams, adapt to changing environments and lead without authority during escalations.
Preferred Experience:
- Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery.
- Preferred knowledge in PL/SQL, Python and Power BI.
- Present technical and/or functional solutions based on the business requirement of the Manufacturing system.
- Significant experience in developing and configuring with Empower, LIMS Software and QC Lab Solutions.
Education/Qualifications:
- Bachelor’s degree in a relevant biotech area (e.g. pharmaceutical and biotechnology) or equivalent.
Additional Information:
- This is a permanent, full-time position.
- This position is 100% home/remote based in Poland.
- Due to the global character of this role business travel is required ca. once every three months to our European manufacturing sites.
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.