Microbiology Validation Specialist

2 weeks ago

Liverpool, United Kingdom Seqirus A CSL Company Full time

Reporting to the Senior Manager, Global Microbiology QC, and based at CSL-Seqirus Liverpool the role is accountable for Quality Control method validation lifecycle management and method standardisation of Microbiological methods.

The Quality & Validation specialist is an SME in Microbiological testing methodology, able to troubleshoot technical issues, develop current and existing methods and be current with the latest in rapid and alternative microbiology testing technologies.

The role requires SME input into regulatory filings/audits.

Principal Accountabilities
- Writes method validation protocols and reports, technical studies and reports, Standard Operating Procedures (SOPs) independently.
- Executes method validations and lab studies independently. Supports QC analysts in executing validation and technical studies when required.
- Meets Quality compliance criteria in line with global and local procedures.
- Leads method transfer, validation, and verification projects.
- Supports QC improvement projects. Shows awareness of QC workflows to suggest improvements in Operational performance.
- Supports QC lab as SME for moderately complex investigations.
- Attends project related meetings as departmental representation as required.

Knowledge, Skills, and Competencies
- Fluency in English
- cGMP background in the pharmaceutical industry
- Subject matter expert in Microbiological Assays (Sterility, Endotoxin, Bioburden)
- Proven time management skills for planning and schedule of work
- Proven Communication skills both written and verbal.
- Knowledge of continuous improvement techniques and advanced root cause analysis techniques
- Influences others within job area through explanation of facts, policies, and practices.
- Knowledge and experience of PCR assays (desirable)

**Qualifications**:

- Bachelor’s degree in a relevant scientific discipline (Microbiology, Biochemistry, Biology etc.)
- Proven lab experience

Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the

benefits

you can participate in when you join CSL Seqirus.

About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL

Seqirus


We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about

Diversity & Inclusion

at CSL Seqirus.

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