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Sterility Assurance specialist

3 months ago

Cork, Cork, Ireland Cpl Full time

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 July 2024

Contact Jenn Dinan on or email -

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 -