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Senior Validation Specialist in Analytical Science and Technology
2 months ago
Position Overview
As a Senior Validation Specialist within the Analytical Science and Technology division at CSL Seqirus, you will play a crucial role in overseeing the lifecycle management of Quality Control method validation and ensuring method standardization and robustness. Your expertise in testing methodologies will be vital for troubleshooting technical challenges, enhancing existing methods, and staying abreast of the latest advancements in analytical testing technologies.
Key Responsibilities
- Ensure compliance with the Quality Control method validation lifecycle.
- Address and resolve technical challenges associated with Quality Control testing methods.
- Facilitate intra-site method transfers and provide subject matter expert (SME) input for regulatory submissions and audits.
- Oversee the execution of method standardization and robustness initiatives.
- Develop and refine both current and new testing methodologies.
- Engage with cutting-edge testing technologies to enhance operational efficiency.
- Take accountability for the Quality Control method validation lifecycle and improvements at the Liverpool site.
Qualifications
- Proven expertise in analytical chromatographic techniques, including HPLC and UPLC.
- Background in the pharmaceutical industry, particularly with biologics such as PAGE and CE.
- Experience in assay development and validation, managing the lifecycle from proof of concept to registration.
- Familiarity with Quality Control testing methodologies and industry standards.
- Strong time management skills for effective planning and scheduling of tasks.
- Excellent communication abilities, both written and verbal.
- Knowledge of continuous improvement strategies and advanced root cause analysis methodologies.
- Bachelor's degree in a relevant scientific field, such as Chemistry or Biochemistry.
- Desirable experience in process or product characterization utilizing various orthogonal methods.
Note: Different qualifications or responsibilities may apply based on local legal and/or educational requirements.
About CSL Seqirus
CSL Seqirus is a global leader in influenza vaccine provision and a significant contributor to global influenza prevention efforts. As part of CSL Limited, we are committed to diversity and inclusion, reflecting the world around us in our workforce.
Our Commitment
At CSL Seqirus, we value our employees and are dedicated to fostering a workplace that promotes professional growth and development.
