Senior Microbiologist

As a Microbiological and/or Chemical Testing Coordinator at Stryker, you will be responsible for coordinating microbiological and chemical testing, as well as releasing products and testing validation protocols. You will perform organism identification and conduct technical reviews of batch filling records to ensure the quality of aseptic processes. Your role will also involve reading and interpreting microbiological cultures and related tests such as environmental monitoring, sterility tests, growth promotion, microbial limits tests, and antimicrobial effectiveness tests. You may be required to perform validation, technology transfer, troubleshooting, and contribute to writing policy procedures for quality initiatives. Additionally, you will review and approve environmental monitoring data, laboratory equipment, and records. Your responsibilities will include preparing process and status reports, assigning and monitoring document numbers, and reviewing documents for accuracy and completeness. Key Responsibilities: - Coordinating microbiological and/or chemical testing - Reviewing and approving quality records and validations - Troubleshooting, non-conformance handling, supplier management, and communication - Ensuring high quality in Micro & Sterility - Performing monitoring oversight and data trending - Driving Corrective and Preventive Actions (CAPAs) and improvements as a Procedure Owner - Ensuring Regulatory Compliance (Internal/External Audits, Tech Files, Standards, ISO 19227, laws, GMP) - Developing Process Control and Validation Strategy for Micro/Cleaning/Sterility - Serving as Subject Matter Expert for Major Changes/PT (GIA MicroBio) and supporting New Product Introduction (NPI) by monitoring deviations, alerts, action limits, non-conformances, and CAPAs Qualifications Required: - Strong coordination, delegation, communication, stress management, and resiliency skills - Commitment to relentless pursuit of quality - Proficiency in ValGenesis, NC/CAPA (Trackwise), Change Management (OnePLM) - Subject Matter Expertise (SME) in core competencies - Understanding of Product Cleanliness - Familiarity with Cleanroom/Environmental Monitoring/Testing - Knowledge of Sterilization (EO) - Proficiency in English and either German or French Please note that Stryker is a global leader in medical technologies dedicated to improving healthcare outcomes. The company collaborates with customers to offer innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine, impacting over 150 million patients worldwide annually.,