Senior Staff Microbiologist (m/w/d) Sterilization Lead
Senior Staff Microbiologist (m/w/d) Sterilization Lead
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Job Description
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
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Travel Percentage: 10%Required Experience:
Staff IC
Employment Type
Full-Time
