Senior Staff Microbiologist

Strategic Vision Capital SA seeks a Senior Staff Microbiologist in Selzach for a 12-month hybrid contract. This non-lab role focuses on global sterility compliance and technical leadership for medical devices.

This position serves as the primary technical authority for microbiology within a global medical device organization. The specialist provides critical guidance on sterility compliance across multiple sites, acting as a subject matter expert without being tied to laboratory work. The role ensures that sterilization processes and quality standards meet rigorous international regulations.

Responsibilities

• Align environmental and utility monitoring, bioburden, and endotoxin testing protocols across all global sites.
• Execute, review, and approve validations and re-qualifications for Gamma and Ethylene Oxide sterilization methods.
• Apply statistical methods to interpret sampling data, establishing control limits and identifying trends.
• Provide technical leadership for resolving Non-Conformances and Corrective and Preventive Actions (CAPA).
• Lead microbiology-related root-cause analysis and problem-solving within cross-functional teams.
• Act as the subject matter expert during audits of supplier quality activities.
• Identify opportunities to stabilize trends and improve statistical control to reduce costs.
• Mentor internal teams and cross-functional groups on microbiology best practices.
• Advise on internal and external regulatory requirements regarding sterility and microbiology.
• Develop, maintain, and improve relevant policies and standard operating procedures.
• Ensure new products adhere to site-specific sterility standards.
• Oversee and approve biocompatibility assessments for components and materials.
• Conduct technical risk assessments for SofHA related to sterility and microbiology.
• Drive projects from initiation to successful completion.

Requirements

• Bachelor’s degree in Microbiology or a closely related field.
• At least six years of experience in microbiology.
• Minimum of eight years working in Quality or Regulatory Affairs.
• Proven experience interacting with regulatory bodies such as the FDA, MoH, or TUV.
• Deep understanding of US and international medical device regulations and standards.
• Strong abilities in communication, project management, and influencing stakeholders.
• Experience leading or managing personnel.
• High proficiency in statistical techniques, data review, and analysis.
• Competence in Microsoft Word, Excel, and PowerPoint.

Nice to have

• Lead auditor certification.

What the company offers

• Hybrid work flexibility.
• 12 month fixed term contract.