CLS is Ireland’s leading provider of sampling, analysis and on-contract analysts to the food, environmental, pharmaceutical and medical device industries. Founded in 1994, CLS is renowned for delivering high-quality laboratory data, always on time and in the most customer-focused way.
CLS is currently going through an unprecedented and exciting period of growth and development and is now looking to hire a Sterility Technician for one of our client sites. This would be a permanent position to include:
The Sterility Technician responsible for the carrying out routine microbiology laboratory activities including environmental monitoring of cleanrooms; microbial analysis of site utilities and testing of raw material, commercial, clinical and development batches. Further, the position holder will manage the microbial analysis of products included in the Global Stability program. Microbial monitoring and testing is performed in line with regulatory requirements.
KEY DUTIES AND RESPONSIBILITIES: | % of Time or Importance |
| Perform key tasks for release and stability testing such as: Environmental Monitoring Water Sampling Bioburden Endotoxin Growth Promotion In-process Testing Sterility Testing APET Antibiotic Assay | 60% |
| Report writing. | 10% |
| Draft and review documentation –SOPs, protocols, training modules, investigations, reports, CAPAs and deviations. | 15% |
| Trending of results and preform investigations into adverse or out of limit results | 10% |
| Validation of equipment and microbiology test methods | 5% |
Job QUALIFICATIONS (MINIMUM REQUIREMENTS)
Education and Experience
- 3rd Level Qualification in Microbiology or equivalent scientific degree
- 12 months working in a manufacturing environment. Preferably Aseptic processing.
- Working knowledge of both Pharmaceutical Industry and sterile processing.
- Strong background in Aseptic’s and/or Microbiology
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- Achieves a high level of competency in laboratory methods and procedures to support raw material, utility, in process, release and stability testing of sterile products.
- Performs routine and non-routine Microbiological testing activities as required.
- Ensures that all testing is completed, reviewed and approved within agreed turnaround times.
- Ensures activities are carried out in compliance with product license commitments, cGMP, company quality standards and legislative regarding health, safety and environment.
For more information or to apply for the role by submitting your CV, please email careers@cls.ie.
CLS is an equal opportunities employer.
CLS will only be responding to those progressing to the next stage.