Microbiologist

Full Job Description

The Microbiologist will be primarily responsible for the sterility compliance of Strykers product in accordance with relevant regulatory requirements and standards for medical devices. The microbiologist will oversee and ensure sustained levels of sterility compliance through testing, monitoring and validation of cleaning and sterilisation processes and associated utilities.

Will work within the microbiology team, under general supervision, with responsibility to ensure effective and efficient cleaning and sterilization practices, which includes, but not limited to the following:

• Oversight of environmental monitoring of cleanrooms in line with ISO 14644 standards, and monitoring of utilities including all grades of water, and where necessary, compressed air, bioburden and entoxin testing.
• Review/writing of cleaning protocols and reports in line with ISO 19227 standards
• Oversight of EtO sterilization processes. Validation and monitoring in line with ISO 11135
• Oversight of radiation sterilization processes. Validation and monitoring in line with ISO 11137
• Interpreting sampling and monitoring data, appliying statistical and analysis techniques, to determine control and trending. Indentifies and initiates when to take action.
• Leads NC and CAPA generation and resolution within the Microbiology group and across related business units. Strong competency in troubleshooting, correction of NC and root cause analysis.
• Act as technical lead for microbiology in cross functional groups including product and process issues, rootcausing, projects, initiatives and other business critical forums..
• Review of cleaning and sterilization validation files for compliance.
• Strong interactions, maintainance and support of sterile finished goods suppliers.
• Interact with Supplier quality team with respect to vendor sterilization topics.
• Performs sterilization release review, intepreting data and trends.
• Continually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving.
• Mentors and trains team and cross functional groups as required
• Subject matter expert to internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)
• Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.
• Coach, mentor and train other functions in area of sterility and monitoring.
• Support of, ensure compliance of new products to sites’ cleaning and sterilization standards. Ensure successful integration of products into validated processes.
• Provides Technical Assessment for completion of Risk Assessment for SofHA in area of sterilization and microbiology.
• Demonstrate technical supervisiory capabilities and leads projects to completion
• Demonstrates knowledge of the business processes and products across multiples sites.

• Masters of Microbiology or equivalent related subject required,
• Strong interpersonal skills.
• Strong written and oral communication and negotiations skills.
• Strong in critical thinking and "outside the box" thinking.
• Highly developed problem solving skills.
• Strong analytical skills.
• Demonstrated ability to successfully manage and complete projects in a matrix organization.
• Demonstrated ability to work independently.
• Experience in working in a compliance risk situation.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages
• Some travel may be required.