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Senior staff microbiologist (m/w/d) sterilization lead

Freiburg (Elbe)
Stryker
Inserat online seit: 12 September
Beschreibung

As a Senior Staff Microbiologist (m/f/d) Sterilization Lead, you will play a key role in ensuring the sterility and microbiological safety of Stryker products. You will provide technical leadership on sterilization (EtO, Gamma) and microbiology topics, partner with cross-functional teams and external providers, and drive process improvements. This position reports into the Quality function and offers the opportunity to influence both strategy and daily operations in a highly innovative environment. What will you do: Lead microbiological monitoring of sterilized medical devices, cleanroom environments, and utilities, including water quality and compressed air systems. Analyze sampling and monitoring data using statistical methods, identify trends, and recommend actions. Provide technical leadership on sterilization topics (focus EtO, secondary Gamma) to support products, processes, root cause investigations, and cross-functional projects. Collaborate closely with external sterilization providers on validations, alignments, and process improvements. Plan, execute, analyze, and document sterilization validations and requalifications in line with ISO standards (e.g., ISO 11135, ISO 11137). Ensure Good Laboratory Practice (GLP) across laboratory activities, including inventory management. Identify and implement improvements in trend stabilization, statistical process control, and cost reduction. Contribute to the development and improvement of policies and standards, and provide technical assessments to support risk analyses. What will you need: _Required:_ University degree in microbiology, biology, chemistry, or a related field. 5 years of relevant experience in microbiology, sterilization, or quality within the medical device, pharmaceutical, or related industries. Strong expertise in sterilization processes (EtO, Gamma) and microbiological testing methods. Proven ability to analyze complex problems and deliver innovative solutions. Excellent communication and collaboration skills, with experience working cross-functionally and with external partners. Fluent German and English skills. _Preferred:_ Experience with ISO 11135 / 11137 and GLP requirements. Knowledge of Lean and process optimization methodologies (e.g., Six Sigma). Prior experience in risk management, audits, or regulatory compliance. Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity. Additional information Please note that the internal job title may differ from the ad title. Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. 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 u2013 M/F/Veteran/Disability.

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