Microbiologist – Pharmaceutical – Permanent – Galway!
This job will suit a Microbiologist with 3 + years’ experience in an GMP facility. Experience in cell culture based manufacturing and molecular techniques, including polymerase chain reaction and sequencing, is highly desirable.
For a detailed job description or a confidential discussion please contact me!
Authoring microbiological related plans, protocols, reports, SOPs and other relevant GMP documents. Oversee the generation of Work Instructions (WIs) and Standard Operating Procedures (SOPs) as pertains to microbiological activities. Performing environmental monitoring performance qualifications and routine environmental monitoring programs. Performing laboratory-based assays, such as but not limited to growth promotions, gram staining, colony counting, microbial Identification Assays, sterility testing, endotoxin testing etc. Subject matter expert and lead in all microbiological related Out of Specification (OOS) or Out of Trend (OOT) analytical results, deviations, investigations, corrective or preventive actions. Contribute to aseptic process simulations/media fills as required. Train others in laboratory procedures where required and execution of analytical testing for microbiology requirements to support any QC, R&D or Manufacturing activity.
Assist at regulatory authority inspections and meetings with health authorities if required.
- 3rd level qualification – Bachelor’s degree in a chemistry-based discipline
- 3+ years Microbiology experience in a GMP Facility
- Thorough knowledge of US and European GMPs and Pharmacopeia.
- Expertise in contamination control of GMP cleanroom facilities.
- Subject matter expert with practical experience of environmental monitoring testing and product testing (e.g. sterility, mycoplasma, endotoxin).
- Attention to detail and application of laboratory safety practices.
- Excellent written and verbal communication and the ability to multi-task across multiple products and programs is highly important.
- Proficient in technical writing and experience in creating; SOPs, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.
For further information or a confidential discussion please contact Aisling Gorman