Sterility Assurance Scientist
Location: Cork
Duration: 12 months
Hours: 39 hours
The Sterility Assurance Scientist is responsible to support the end-to-end implementation of contamination control and sterility assurance policies for the manufacturing of commercial products within Global Orthopedics. The defined make organizations include Cork, Ireland, as well as supporting defined suppliers.
The Sterility Assurance Scientist will support in the areas of aseptic processing, contamination control, sterilization, reprocessing and microbiology. He/she will support product manufacturing activities.
Roles and Responsibilities
R&D
provide technical support in the validation of aseptic manufacturing and sterilization methodologies
support contamination control and sterility assurance requirement in the integration of acquisitions and new product licensing
provide support in the development of design history files and regulatory submissions to ensure compliance to applicable regulations and standards internationally
Plan
provide support in the development of new manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third-party manufacturers)
Source
provide support in due diligence for sterile, non-sterile or microbiologically controlled manufactured products, and provide technical SME support for integration into J&J
provide technical SME support for procurement activities that relate to sterile, non-sterile or microbiologically controlled products that are externally manufactured
support requirements for new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization and reprocessing
provide support in the design of critical water and air systems and the design of controlled environments and cleanliness control strategies
provide technical SME support for sterility assurance and contamination control in supplier audits.
Make
support cross-functional compliance to the end-to-end sterility assurance policies at defined manufacturing facilities in Cork, Ireland
ensure process changes meet contamination control and sterility assurance requirements
support the investigation, gap analysis and develop the corrective action plan for microbiological or contamination control CAPAs and non-conformances, including root cause identification and corrective action implantation within agreed timelines
supports technical assessments of third party manufacturers, sterilization contractors, external laboratories and other applicable suppliers.
provide technical support during onsite inspections
work with internal and external laboratories to support sterility assurance testing requirements.
work with the local Sterilization Execution organization to support the release of sterile product, and addressing any issues that might arise during the execution of the sterilization processes
Deliver
support the ongoing initiatives regarding the validation of primary non-sterile and sterile packaging systems that meet the needs of distribution system and delivery of sterile or microbiologically controlled product to the patient and/or consumer
External Influencing
develop knowledge on best practices in sterility assurance and contamination control by interacting with JJSA leadership.
Internal Influencing
interacts with product development teams to ensure objectives and project timelines meet business needs. Interacts with their peers in sterility assurance to utilize resources and ensure best practices across facilities.
participate on the J&J Sterility Assurance Councils
How to Succeed
An undergraduate (BS) degree with Microbiology, Biology, Engineering or related discipline is required; an advanced degree is desirable.
A minimum of 1 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.
Benefits
This role offers a very competitive hourly rate. This contract will run for 12 months.
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