Senior Scientist, QC Excellence Instrumentation Specialist

vor 14 Stunden


Bern, Bern, Schweiz CSL Vollzeit

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In this role, you will support laboratory instrumentation and automation infrastructure in the operational QC testing environment. Your responsibilities will include ensuring laboratory instrumentation and equipment are qualified, calibrated, and maintained according to company policies and procedures and in compliance with GxP requirements.

Key Responsibilities:

  • Support laboratory instrumentation and automation infrastructure in an operational testing environment
  • 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
  • Ensure laboratory instrumentation and equipment are qualified, calibrated, and maintained according to company policies and procedures and in compliance with GxP requirements
  • Support update of procedures related to laboratory instrumentation and computerized systems to ensure compliance with guidelines and industry best practice
  • First-level user support for operational QC labs on instrumentation providing technical support, coordinating repairs, and support through QC external providers

About You:

In this role, you will collaborate with relevant stakeholders to ensure laboratory equipment and automation systems are operating in a qualified environment. With your proactive and self-responsible approach, you will take decisions and drive progress forward.

Requirements:

  • University degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, Bioinformatics, Computer Science, etc.)
  • 5+ years' experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation, 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 willingness to extend skills and know-how on the field
  • Strong written and verbal communication in German and English, both oral and written to ensure effective collaboration with cross-functional teams both locally and globally across all CSL Behring sites
  • Strong analytical/problem-solving, technical IT affinity, and organizational skills
  • Able to work independently and as a team member in a high-performance environment


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