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Senior Scientist, QC Excellence Instrumentation Specialist

vor 2 Monaten


Bern, Bern, Schweiz CSL Behring Vollzeit
About the Role

We are seeking a highly skilled Senior Scientist to join our team at CSL Behring. As a Senior Scientist, QC Excellence Instrumentation, you will play a critical role in supporting laboratory instrumentation and automation infrastructure in our operational QC testing environment.

Key Responsibilities:

  • Support laboratory instrumentation and automation infrastructure in an operational testing environment, ensuring seamless integration and optimal performance.

  • Develop and implement qualification, validation, and lifecycle management strategies for laboratory automation systems, analytical instruments, and software applications.

  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements, such as GxP, USP, 21CFR Part 11, and Annex 11.

  • Manage local and global qualification and validation projects, ensuring timely and cost-effective delivery.

  • Provide technical support and guidance to internal stakeholders, including first-level user support for operational QC labs.

  • Develop and maintain documentation, including technical requirement specifications, data integrity plans, and automation activities.

  • Stay up-to-date with industry best practices and regulatory requirements, ensuring our laboratory instrumentation and automation infrastructure remains compliant and effective.

Requirements:

  • University degree in a relevant scientific discipline, such as Biology, Microbiology, Chemistry, Bioinformatics, or Computer Science.

  • 5+ years' experience in a pharmaceutical GMP testing environment, with expertise in equipment qualification, CSV, and lifecycle activities.

  • First project management experience in an operational environment, with a proven track record of delivering projects on time and within budget.

  • Strong written and verbal communication skills in English and German, with the ability to collaborate effectively with cross-functional teams.

  • Strong analytical and problem-solving skills, with a technical IT affinity and organizational skills.

  • Able to work independently and as a team member in a high-performance environment.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. We believe that a diverse and inclusive workplace is essential for innovation, creativity, and success.