Job Description

Work Flexibility: Onsite

12 month Stryker contract with full benefits.

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

• Environmental monitoring of cleanrooms for viable air, viable surface and particulate in line with ISO 14644 standards.
• Monitoring of utilities including all grades of water, and where necessary, compressed air.
• Co-ordination of samples for bioburden and endotoxin testing.
• Ordering consumables (media etc) and general stock for day-to-day running of laboratory.
• Applying cGLP to all laboratory activities including stock control.
• Performing sampling for validations and re-qualifications as required. Review of validation files for compliance.
• Strong interactions, maintainance and support of sterility suppliers.
• Interact with Supplier quality team with respect to vendor sterility topics.
• Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending.
• 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.
• Performs sterility release review, interpreting data and trends.
• Performs sterilisation validations and re-qualifications in line with relevant BS EN ISO standards.
• 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 (induction, GMP etc)
• 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’ sterility standards. Successful integration of products to validated processes.
• Ensures biocompatible of components, materials and consumables used in the manufacture of Stryker product.

What you will need:

Bachelor degree/ Masters of Microbiology (Level 8)

2 years Microbiology related experience.

Travel Percentage: None