Archiviertes Projekt - Laboratory Systems Analyst (m/w/d)

Job Description:
Your responsibilities include, but are not limited to:
• Assess laboratory instruments and software for their compliance with Data Integrity guidelines.
• Implement Data Audit Trail Reviews for laboratory instruments and software in accordance with the guidelines.
• Create documentation in English and German for qualification, validation and lifecycle management of existing and newly implemented laboratory automation systems, analytical instruments, and software applications in collaboration with Engineering and I&T departments
• Manage local and global qualification and validation projects.
• Collaborate with internal and external stakeholders within qualification and validation projects for technical requirement specifications, data integrity, and automation activities.
• Support the update of procedures related to laboratory instrumentation and computerized systems (i.e., USP, 21CFR Part 11, Annex 11 regulations) to ensure compliance with guidelines and industry best practices, as well as harmonization within the global organization.

Who you are: In this role, you will collaborate with relevant stakeholders to ensure laboratory are complient with Data Integrity guidelines by implementing a Data Audit Trail Review process. With your proactive and self-responsible approach, you take decisions and drive progress forward.

The below competencies will help you to be successful in this role:
• University degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, Bioinformatics, Computer Science, etc.).
• 3+ years’ experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation, with experience in equipment qualification or CSV and lifecycle activities.
• First project management experience in an operational environment.
• Knowledge of regulations on computerized systems and laboratory automation, and a willingness to extend skills and know-how in the field.
• Strong written and verbal communication skills in German and English, both oral and written, to ensure effective collaboration with cross-functional teams both locally and globally across all sites.
• Strong analytical/problem-solving skills, technical IT affinity, and organizational skills.