Staff Microbiologist

• 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, bio-burden and endotoxin testing.
• Interpreting sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending. Identifies 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, root causing, projects, initiatives and other business critical forums.
• 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, maintenance and support of sterility suppliers.
• Interact with Supplier quality team with respect to vendor sterility topics.
• Performs sterility release review, interpreting data and trends.
• Performs sterilization 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. Ensure successful integration of products into validated processes.
• Ensures biocompatible of components, materials and consumables used in the manufacture of Stryker product.
• Provides Technical Assessment for completion of Risk Assessment for SofHA in area of sterility and microbiology.
• Demonstrate technical supervisory capabilities and leads projects to completion
• Demonstrates knowledge of the business processes and products across multiples sites.

Requirements:

• Bachelor's Degree in Microbiology or a related discipline (Genetics, Cell Biology, Biology, etc.)
• 4+ years of experience in microbiology laboratory testing, cleanroom monitoring, and/or sterilization process monitoring
• Sterilization certificate and/or training
• Lead Auditor training and/or certification
• Experience in medical device, biologics and/or pharmaceutical industries
• Excellent verbal and written communication skills