Kenny-Whelan, a specialist division of the CPL group, is hiring a Sterility Assurance Specialist to work on contract at our client's site, Depuy, in Ringaskiddy Cork.
Job Description
The individual will support end-to-end contamination control and sterility assurance practices for new product development and/or sustainment of commercial products within Global Orthopedics.
Key Responsibilities:
1. Aseptic processing, cleaning, and disinfection requirements
2. Sterilization validation (EO, gamma, electron beam, moist heat, and dry heat processes)
3. Reprocessing, microbiological testing, bioburden, tests of sterility, endotoxin monitoring
4. Environmental control and monitoring
5. Water and air systems validation
6. Sterility assurance support to new product development and launch, compliance with applicable regulations and standards
7. Inspection and submission support, Health-based risk assessment
Job Qualifications
* Experience in microbiology, sterilization validation, and environmental controls for medical device or pharmaceutical manufacturing facilities
* Minimum 2 years experience as a microbiologist in a regulated industry
* Knowledge of US FDA (QSR) regulations and ISO 13485
* Strong knowledge in competent authority regulations and industry guidelines for environmental monitoring and microbiological control of medical devices
* Experience of GMP audits and internal/external audits
* Proven knowledge and demonstrated capability of product verification and process validations
* Good interpersonal and organizational skills, comfortable working with cross-functional teams, excellent communication skills, strong attention to detail
Required Education and Experience
* Undergraduate degree in Microbiology, Biology, Engineering, or related life science discipline
* Minimum 2 years of experience in a GMP and/or ISO regulated environment in the medical device or pharmaceutical industry
* Competent in using computer software such as Excel, Word, PowerPoint, and analytical software
This position will report into a Sterility Assurance Supervisor or Sterility Assurance Manager.