As a Senior Scientist Digital Quality Control, you will play a key role in bringing our global QC digitalization strategy to life. You will collaborate with QC teams worldwide to implement a global Laboratory Execution System (LES), enabling the transition from paper-based laboratory documentation to digital method workflows. As part of a global QC team, you will create and verify digital method workflows, maintain global process documentation, and support implementation activities at our sites in Australia, Germany, Switzerland, and the United States.
Responsibilities:
- Create digital method workflows in the BIOVIA ONE Lab Laboratory Execution System based on analytical method SOPs and process maps structured according to ISA-88 principles.
- Create and execute test cases to verify digital method workflows.
- Manage the lifecycle of digital method workflows, including master and dynamic data management, as a Business Administrator for BIOVIA ONE Lab.
- Develop User Requirements Specifications (URS) for laboratory instrument interfaces.
- Maintain global process documents related to the QC Laboratory Execution System.
- Support QC business process standardization and global data integrity initiatives related to laboratory automation and analytical instrumentation.
Qualifications:
Education
- University degree in a relevant scientific discipline (e.g., Biology, Chemistry, Microbiology, or a related field).
Experience
- 3-5 years of experience in a pharmaceutical GMP testing environment, including the use of a variety of analytical instruments, instrument lifecycle management activities, and data integrity practices.
- At least 2 years of experience working with laboratory automation systems in a QC or R&D environment.
- Experience with BIOVIA ONE Lab or a comparable Laboratory Execution System is considered an advantage.
- Knowledge of GMP computerized system regulations and industry guidance, including GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles, is desirable. A strong willingness to further develop expertise in this area is expected.
Competencies
- Strong written and verbal communication skills in English, with the ability to collaborate effectively with cross-functional teams across global CSL Behring sites.
- Strong analytical and problem-solving skills, a high affinity for digital technologies and IT systems, and excellent organizational abilities.
- Ability to work both independently and collaboratively in a fast-paced, high-performance environment.
The expected base salary range for this position at hiring is $71,000 - $90,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
