Kenny-Whelan (a specialist division of the CPL group) are hiringa Sterility Assurance Specialist to work on contract at our clients site , Depuy, in Ringaskiddy Cork NEW vacancy Jan 2025 ContactJenn Dinan onoremail 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 and email Skills: Microbiology Sterility Assurance GMP Bioburden Endotoxin Benefits: Paid Holidays Parking Staff Discounts