Description
A Bio-pharmaceutical company located in Limerick is seeking a Senior QC Microbiology Scientist.Summary: Perform method development, optimization and validation for the QC Microbiology group. Provide technical support and guidance for release testing, in-process testing, and microbiological investigations. Provide technical expertise in regards to Environmental Monitoring
Essential Duties and Responsibilities include, but are not limited to, the following:
- Method and equipment validation related to: sterility/bioburden/endotoxin testing, and microbial identifications
- Technical writing including: position papers, validation reports, and microbiological investigations.
- Organism culture, research, and characterization for use in investigations and cleaning development
- Strong background in pharmaceutical microbiology, GMP working experience in QC lab and aseptic techniques are required.
- Strong investigational skill, working knowledge of microbiology assay development and validation are needed.
- Advanced knowledge of aseptic manufacturing operations required.
- Reviews new test procedures and assays
- Evaluate and acquire new methodologies, techniques, and equipment as needed.
- Oversee Contract laboratory testing.
- Set product specifications and alert/action levels
- Lead technical troubleshooting and problem investigations.
- Review assay, process, and equipment validation reports, as well as, other technical documents for technical correctness and regulatory compliance.
- Coach junior member of the team for good microbiology lab practice and modern aseptic techniques
- Lead in the audit of vendors, external laboratories, business partners, and contracted manufactures as needed
- Support and participate in regulatory inspections
Education and Experience:
- QC Scientist: Requires Ph.D in Microbiology or related field, with 3-6+ years of relevant experience
- QC Specialist: Requires Bachelor's degree in Microbiology or related field, with 15+ years of relevant experience or advanced scientific degree such as a MS with 10+ years of relevant experience
An extremely attractive salary and benefits package is on offer. If you have the essential skills and experience please contact me Anna Mooney or reply with an up to date CV.