Staff Microbiologist
Employment Type : Full-Time
Responsibilities:- 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