At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com Job Function Quality Job Sub Function Quality Assurance Job Category Professional All Job Posting Locations Ringaskiddy, Cork, Ireland Job Description This is a contractor conversion.
Therefore we are not going to consider other applicants for this role.
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, and 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.
R&Dprovide technical support in the validation of aseptic manufacturing and sterilization methodologiessupport contamination control and sterility assurance requirement in the integration of acquisitions and new product licensingprovide support in the development of design history files and regulatory submissions to ensure compliance to applicable regulations and standards internationally Planprovide support in the development of new manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third‑party manufacturers)Sourceprovide support in due diligence for sterile, non‑sterile or microbiologically controlled manufactured products, and provide technical SME support for integration into J&Jprovide technical SME support for procurement activities that relate to sterile, non‑sterile or microbiologically controlled products that are externally manufacturedsupport requirements for new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization and reprocessingprovide support in the design of critical water and air systems and the design of controlled environments and cleanliness control strategiesprovide technical SME support for sterility assurance and contamination control in supplier audits Makesupport cross‑functional compliance to the end‑to‑end sterility assurance policies at defined manufacturing facilities in Cork, Irelandensure process changes meet contamination control and sterility assurance requirementssupport 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 timelinessupport technical assessments of third‑party manufacturers, sterilization contractors, external laboratories and other applicable suppliersprovide technical support during onsite inspectionswork with internal and external laboratories to support sterility assurance testing requirementswork 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 Deliversupport 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 Influencingdevelop knowledge on best practices in sterility assurance and contamination control by interacting with JJSA leadership Internal Influencinginteracts 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 The Sterility Assurance Scientist 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, compliance to applicable regulations and standards in the subject areas of sterility assurance and laboratories.
Job Qualificationsqualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facilitydemonstrated competency in multiple healthcare and industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat) is requiredproven track record on troubleshooting process non‑conformances and out of specification test results, and providing resolution to issues by a robust CAPA processexperience in interacting with Regulatory Authorities is preferredexperience with conducting technical assessments of in‑house and external manufacturing and terminal sterilization is preferredknowledge of standards including EU, USA and ISO is requiredexcellent oral and written skills and able to communicate both up and down the business ladder within franchise or technical competency area is requireddemonstrated ability to work in a collaborative/teamwork environment is requiredindependent organizational and time management skills is required Required Education And Experiencean undergraduate (BS) degree with Microbiology, Biology, Engineering or related discipline is required; an advanced degree is desirable.a minimum of 3 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 Power Point, and analytical software.
Supervisor This position will report into a Sterility Assurance Supervisor
#J-18808-Ljbffr