Shane Walsh
Dublin
Summary
Results-driven Micro-Sterility Analyst at Viatris with expertise in sterility and endotoxin testing. Proven ability to lead teams and enhance operational efficiency while ensuring compliance with industry standards. Skilled in environmental monitoring and cell culture maintenance, fostering a culture of excellence and safety in laboratory settings.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Micro-Sterility Analyst
Viatris
Dublin
02.2023 - Current
- Conducted sterility testing within a grade A isolator for product in multiple presentations, powder in vials, liquid in vials, and pre-filled syringes.
- Performed environmental monitoring in grade D environments to ensure compliance.
- Executed endotoxin testing using gel clot and kinetic turbidimetric methods.
- Completed growth promotion testing of sterility media to validate efficacy.
- Conducted device testing focusing on dose accuracy, friction force, dimensions, and seal integrity.
- Maintained mammalian cell cultures for bioassay applications.
- Validated new products through compendial testing for sterility and endotoxin levels.
- Reviewed batches for compliance with quality standards.
Sequencing Team Leader
Source BioScience
Dublin
10.2020 - 10.2022
- Supervised a small team of analysts to perform Sanger sequencing and genotyping testing for clients.
- Trained new employees to ensure task proficiency and operational effectiveness.
- Conducted performance reviews and delivered feedback to support employee development.
- Acted as site first-aid responder to ensure safety and health compliance.
- Coordinated lab relocation from Dublin to San Diego.
- Partnered with US team to establish local client relationships.
Microbiologist
Source BioScience
Tramore
09.2019 - 09.2020
- Established operational procedures for microbiology prior to service launch.
- Collaborated with management to secure initial GMP certification from HPRA.
- Ensured compliance with EMA and HPRA Good Laboratory Practices.
- Conducted compendial verification for new products.
- Performed microbial limit and endotoxin testing for industry clients.
Education
Bachelor of Science - Molecular Biology With Biopharmaceutical Science
Waterford Institute of Technology
Waterford, Ireland06-2018
Skills
- Sterility testing
- Endotoxin testing
- Environmental monitoring
- Microbial limit testing
- Cell culture maintenance
- Compendial testing
Certification
Merck Steritest school, Oct 2023
Timeline
Micro-Sterility Analyst
Viatris
02.2023 - Current
Sequencing Team Leader
Source BioScience
10.2020 - 10.2022
Microbiologist
Source BioScience
09.2019 - 09.2020
Bachelor of Science - Molecular Biology With Biopharmaceutical Science
Waterford Institute of Technology