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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 pivotal role in overseeing the lifecycle management of Quality Control method validation and ensuring method standardization and robustness. Your expertise in testing methodologies will be essential for troubleshooting technical challenges, enhancing existing methods, and staying abreast of the latest advancements in analytical testing technologies.
Key Responsibilities
- Ensure compliance throughout 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.
- Implement and manage method standardization and robustness initiatives.
- Develop and refine both current and novel testing methodologies.
- Stay engaged with cutting-edge testing technologies to enhance operational efficiency.
- Oversee the Quality Control method validation lifecycle, method transfers, and continuous improvements at the Liverpool site.
Qualifications
- Expertise in analytical chromatographic techniques, including HPLC and UPLC.
- Experience in the pharmaceutical industry, particularly with biologics such as PAGE and CE.
- Proficient in assay development and validation, covering the entire lifecycle from proof of concept to registration.
- Familiarity with Quality Control testing methodologies and industry standards.
- Strong time management abilities for effective planning and scheduling of tasks.
- Excellent written and verbal communication skills.
- Knowledge of continuous improvement methodologies and advanced root cause analysis techniques.
- 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: This position is a fixed-term contract.
About CSL Seqirus
CSL Seqirus is a global leader in the provision of influenza vaccines and is a key player in pandemic preparedness. As part of CSL Limited, we are committed to innovation and excellence in the healthcare sector.
Diversity and Inclusion
CSL Seqirus values diversity and inclusion, reflecting the communities we serve across 35+ countries. We strive to create an environment where every employee feels valued and empowered.
Impactful Work
At CSL Seqirus, you will have the opportunity to contribute to meaningful work that makes a difference in public health.
