Kenny-Whelan (a specialist division of the CPL group) are hiring a Sterility Assurance Specialist to work on contract at our clients site , Depuy, in Ringaskiddy Cork
NEW vacancy Jan 2025
Contact Jenn Dinan on 0214665408 or email [email protected]
Sterility Assurance /Microbiologist
Description
The individual is responsible for supporting the end-to-end contamination control and sterility assurance practices for the development of new products and/or sustainment of commercial products within Global Orthopedics.
The Scientist, Sterility Assurance technical areas supported include:
· aseptic processing, cleaning and disinfection requirements,
· sterilization validation (for EO, gamma, electron beam, moist heat, and dry heat processes),
· reprocessing, microbiological testing to support the validation and maintenance of the sterilization processes and product label claims (e.g., bioburden, tests of sterility, endotoxin monitoring),
· environmental control and monitoring,
· water and air systems validation,
· sterility assurance support to new product development and launch, compliance to applicable regulations and standards in the subject areas of sterility assurance and laboratories.
· Inspection and submission support and Health based risk assessment.
Job Qualifications:
· Qualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility
· Minimum 2 years experience as a microbiologist in a medical device, pharmaceutical, or similar regulated industry.
· Knowledge of associated regulations such as US FDA (QSR) regulations and ISO 13485
· Strong knowledge in competent authority regulations and industry guidelines for environmental monitoring (i.e. ISO/EN/AAMI standards) and microbiological control of medical devices is preferred
· Experience of GMP audits, internal and relevant external audits, would be advantageous
· Proven knowledge and demonstrated capability of product verification and process validations.
· Good interpersonal and organizational skills.
· Comfortable to work with cross functional teams.
· Excellent communication skills - Written and Oral.
· Strong attention to detail.
Required Education and Experience:
· An undergraduate (BS) degree with Microbiology, Biology, Engineering or related discipline life science discipline is preferred.
· A minimum of 2 years of experience in a medical device or pharmaceutical (combination) industry with a GMP and/or ISO regulated environment is required.
· Competent in using computer software such as Excel, Word and PowerPoint, and analytical software.
Supervisor: This position will report into a Sterility Assurance Supervisor or a Sterility Assurance Manager.
Contact Jenn Dinan on 0214665408 and email [email protected]