Senior Microbiologist

12 month Stryker contract with full benefits.

Responsibilities

• 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.

Qualifications

• Bachelor degree/ Masters of Microbiology (Level 8)
• 2 years Microbiology related experience.