Senior Microbiologist
Stryker
- Skawina, małopolskie
- Stała
- Pełny etat
- Conduct routine microbiological testing on raw materials, in-process samples, finished products, and environmental samples using a variety of microbiological techniques and equipment.
- Perform microbial identification and enumeration assays, including but not limited to bioburden testing, endotoxin testing, sterility testing, and microbial identification.
- Prepare and maintain microbial cultures and stocks for testing purposes, ensuring accuracy and traceability of test results.
- Interpret and analyze microbiological data, identify trends or deviations, and communicate findings to relevant stakeholders for further investigation or corrective actions.
- Support the development and validation of microbiological testing methods, procedures, and protocols in accordance with regulatory requirements and industry standards.
- Collaborate with cross-functional teams, including Quality Assurance, Research and Development, and Manufacturing, to address microbiological issues and ensure product quality and safety.
- Maintain a clean and organized laboratory environment, adhere to good laboratory practices (GLP), and ensure compliance with all applicable regulatory guidelines and standards.
- Participate in internal and external audits, inspections, and regulatory submissions as needed, providing microbiological expertise and documentation support.
- Stay abreast of emerging trends, technologies, and regulatory developments in microbiology and related fields, and contribute to continuous improvement initiatives within the organization.
- 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.
- Subject matter expert to internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, MDR, 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
- Project team member of the design, installation and certification of the Clean Room and processes running in the supervised work environment
- 4 years of experience in a microbiology laboratory, preferably in a medical manufacturing or pharmaceutical industry setting
- Strong knowledge of microbiological principles, techniques, and methodologies, including aseptic technique, microbial culture, identification, and enumeration methods.
- Experience with microbiological testing equipment and instrumentation, such as autoclaves, incubators, microscopes, and microbial identification systems
- Familiarity with regulatory requirements and standards governing microbiological testing in the medical device or pharmaceutical industry, including FDA regulations, USP, EP, and ISO standards.
- Effective communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and communicate technical information clearly and concisely.
- Detail-oriented approach to work, with a strong commitment to quality, accuracy, and compliance with regulatory requirements and industry standards.
- Certification or licensure in microbiology or related field (e.g., ASM certification, ASCP certification, etc.).
- Experience with validation and qualification of microbiological testing methods, equipment, and processes.
- Knowledge of statistical analysis techniques and software for data analysis (e.g., Minitab, JMP, etc.).
- Experience with quality management systems (QMS), such as ISO 13485, ISO 17025