About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
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 work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately
standards of care.
The Opportunity:
Are you passionate about driving innovation in laboratory systems and ensuring seamless digital integration across global manufacturing environments? We’re looking for a Global QC Labs Lead Application Engineer to join our team in Warsaw and take ownership of critical lab applications used across our global QC labs.
In this role, you’ll be the go-to expert for systems like Labware LIMS, Waters Empower, NuGenesis, Shimadzu LabSolutions, ELN, and Binocs. You’ll ensure these systems run smoothly, are well-integrated with business platforms like SAP and Data Lakes, and support compliance in a regulated (GxP) environment. If you enjoy solving complex problems, collaborating across teams, and making a real impact on global operations—this is your chance.
We welcome experienced professionals and motivated individuals eager to grow in a dynamic, international setting.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.
Key Responsibilities:
- Be responsible for administration, maintenance, and user management of lab systems (e.g. creating roles, managing access, supporting access reviews).
- Ensure seamless integration between lab systems (e.g. LIMS and Empower) and business platforms (e.g. SAP, Data Lakes).
- Maintain CMDB for each of the relevant systems.
- Act as the first point of contact for QC lab users, providing technical support and resolving issues.
- Lead system enhancements and collaborate with vendors to implement changes.
- Monitor system performance and implement improvements to enhance efficiency and user experience.
- Conduct training sessions to ensure proper use of laboratory systems across global teams.
- Represent lab systems during audits and inspections as the subject matter expert.
- Support GxP and non-GxP system operations in line with global procedures and guidelines.
- Collaborate across digital and business units to improve the Scientific IT landscape.
- Contribute to continuous improvement initiatives and drive value through integration and deployment.
Essential Knowledge & Experience:
- Solid and proven experience in scientific IT, ideally in pharmaceutical or biotech environments.
- Hands-on experience with CDS, LIMS, and SDMS systems.
- Strong understanding of manufacturing processes, equipment qualification, and computer systems validation (CSV) according to GAMP 5.
- Excellent communication skills in English (written and spoken).
- Ability to work effectively in a team and adapt to changing environments.
- Experience in defining user stories, conducting impact analysis, and supporting system upgrades.
- Familiarity with privacy laws and security assessments.
- Ability to manage vendor relationships and lead without formal authority.
Preferred Knowledge & Experience:
- Experience with DevOps principles and CI/CD pipelines.
- Knowledge of PL/SQL, Python, and Power BI.
- Experience configuring Empower, LIMS software, and QC Lab Solutions.
- Ability to present technical and functional solutions based on business needs.
Additional Information:
- This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
Astellas’ Global Capability Centres – Overview
Astellas’ Global Capability Centre’s (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
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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