Senior Validation Specialist in Analytical Science and Technology

3 weeks ago


Liverpool, Liverpool, United Kingdom CSL Seqirus Full time

Position Overview

As a key member of the Analytical Science and Technology team at CSL Seqirus, you will oversee the lifecycle management of Quality Control method validation and ensure method standardization and robustness. Your expertise in testing methodologies will be crucial in addressing technical challenges, enhancing existing methods, and staying abreast of the latest advancements in analytical testing technologies. This role includes the execution of method transfers and providing subject matter expert (SME) input for regulatory submissions and audits.

Key Responsibilities

  • Ensure compliance with the Quality Control method validation lifecycle.
  • Resolve technical issues related to Quality Control testing methods.
  • Facilitate intra-site method transfers and contribute to regulatory documentation and audits.
  • Implement method standardization and robustness initiatives.
  • Develop and refine both current and novel testing methodologies.
  • Stay engaged with cutting-edge testing technologies.
  • Take responsibility for the Quality Control method validation lifecycle and 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.
  • Proven track record in assay development and validation throughout the assay lifecycle from concept to registration.
  • Familiarity with Quality Control testing techniques and industry standards.
  • Strong time management abilities for effective planning and scheduling.
  • Excellent written and verbal communication skills.
  • Knowledge of continuous improvement methodologies and advanced root cause analysis.
  • Bachelor's degree in a relevant scientific field, such as Chemistry or Biochemistry.
  • Desirable experience in process or product characterization using various orthogonal methods.

About CSL Seqirus

CSL Seqirus is a leading global provider of influenza vaccines and a significant contributor to global influenza prevention efforts. As part of CSL Limited, we are dedicated to maintaining a diverse and inclusive workforce that reflects the communities we serve.

Our Commitment to Diversity

At CSL Seqirus, we embrace diversity and inclusion as core values. We believe that a diverse workforce enhances our ability to innovate and meet the needs of our customers worldwide.



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