User Project Lead Lab Execution System (LES) - Method Digitization | User Project Lead Lab Execution System (LES) - Methodendigitalisierung (gn)
Akkodis Germany Tech Experts GmbH
Job Summary
We are seeking a User Project Lead for a Lab Execution System (LES) digitization project within a renowned pharmaceutical client near Frankfurt. This role involves preparing and guiding the LES project through gate releases, coordinating key users, external partners, and internal departments to achieve project objectives. You will be responsible for maintaining, optimizing, and harmonizing systems and databases (e.g., SAP, LIMS, OneLIMS), digitizing and harmonizing test methods in the LES environment, and creating GMP-compliant documentation. The position also includes handling events, change controls, CAPAs, and supporting regulatory inquiries. The ideal candidate possesses a Master's or PhD in natural or engineering sciences, or equivalent experience, with a strong background in quality control, laboratory processes, and GxP/cGMP requirements. Experience with method digitization, LIMS/LES systems, and roll-outs is highly desirable. Excellent communication, a structured approach in a GMP environment, and strong digital system affinity are essential.
Required Skills
Education
Master's or PhD in Natural or Engineering Sciences, or comparable qualification with relevant professional experience.
Experience
- Professional experience in quality control and laboratory processes
- Experience with GxP/cGMP requirements
- Experience with method digitization and harmonization in pharmaceutical QC labs
- Experience with LIMS and LES systems is advantageous
- Experience with roll-outs and project phases is advantageous
- Experience in a GMP environment
- LEAN and process optimization experience is desirable
Languages
Additional
- Full-time, permanent contract. Must be willing to work in the Frankfurt area.
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