The person will be primarily responsible for the sterility compliance of Stryker's products in accordance with relevant regulatory requirements and standards for medical devices. The Microbiologist will oversee and ensure sustained levels of sterility compliance through testing, monitoring and validation of cleaning, sterilization processes and associated utilities.

What you will do:

• 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

Who we are looking for:

• 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

Excellent communication Skills in English and Polish

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.