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Global QC labs Lead Application Engineer - Manufacturing Systems

Global QC labs Lead Application Engineer - Manufacturing Systems

Astellas PharmaWarszawa, Województwo mazowieckie, Polska
29 dni temu
Opis pracy

Global QC labs Lead Application Engineer - Manufacturing Systems

Location : Warsaw, Poland (Hybrid work)

Overview

Global QC Labs Lead Application Engineer - Manufacturing Systems. We are 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. You will be the go-to expert for systems like Labware LIMS, Waters Empower, NuGenesis, Shimadzu LabSolutions, ELN, and Binocs, ensuring these systems run smoothly, are well-integrated with business platforms like SAP and Data Lakes, and support compliance in a regulated (GxP) environment.

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 with hybrid working and some office presence. Candidates must be located within a commutable distance of the office.
  • 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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