CSL Behring is a global biotherapeutics leader driven by its promise to save lives.
We are currently looking for a
In the role as Senior Scientist, QC Instrumentation Standards (m/f/d) you will be a key player to bring the global QC digitalization strategy to live! You will actively work with our QC teams around the globe to deliver process automation initiatives such as a global Laboratory Execution System, allowing QC to move from paper-based to digital workflows. You will create digital workflows and establish global process documents while supporting the local implementation at our sites in Australia, Germany, Switzerland, and the United States of America.
Your responsibilities include, but are not limited to:
- Create digital workflows for the implementation of a global Laboratory Execution System
- Establish process documents to support implementation of a global Laboratory Execution System for QC
- Support laboratory instrumentation standardization projects and global data integrity initiatives
- Create process documentation in English for instrument lifecycle management and Laboratory Execution System in collaboration with Engineering and I&T departments
- Support QC Instrumentation site teams on modernization of the QC instrumentation
- Collaborate with internal and external stakeholders within qualification and validation projects for technical requirement specifications, data integrity and automation activities
- Support 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 practice, as well as harmonization within the global organization
Who you are:
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, Chemistry, Microbiology, etc.)
- 3-5 years' experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation, experience in instrument lifecycle activities and data integrity
- Minimum 2 years’ experience with laboratory automation in QC or R&D
- 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 & verbal communication in English 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
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
CSL Behring is committed to provide equal employment opportunity for all.