Staff Scientist - Microbiology & Sterility Assurance (Supplier / External Manufacturing)

We are searching for a Staff Scientist - Microbiology & Sterility Assurance (Supplier / External Manufacturing) to support Microbiological Quality & Sterility Assurance (MQ&SA) across external manufacturing and suppliers within DePuy Synthes (EMEA). In this role we support end to end MQ&SA activities across the supply network, focusing on contamination control, sterilization, cleaning processes and controlled manufacturing environments.

Responsibilities

• Support end to end Microbiological Quality & Sterility Assurance (MQ&SA) activities related to suppliers and external manufacturing processes
• Contribute to change requests and projects impacting controlled environments, cleaning, and sterilization processes
• Support contamination control strategies, including environmental monitoring and investigation activities
• Provide technical guidance and training on microbiological quality and sterility assurance
• Act as a subject matter expert for investigations, CAPA, non conformances, audit observations, and risk assessments
• Support due diligence activities (e.g., acquisitions, partnerships) by providing MQ&SA expertise and risk input
• Support development and updates of supplier quality agreements
• Coordinate and participate in supplier audits, including preparation, on site support, response review, and follow up activities
• Partner with cross functional teams to support supplier qualification and lifecycle management
• Contribute to remediation activities following audits or regulatory findings
• Build strong relationships with external partners, including manufacturers, suppliers, sterilization providers, and testing laboratories
• Coach and support colleagues and partners in MQ&SA practices

Qualifications

• Bachelor's degree in Microbiology, Biological Sciences, Engineering, or a related field
• At least 6 years of experience in microbiology and sterilization assurance within the medical device or pharmaceutical industry
• Strong knowledge of microbiological control, contamination control, and sterilization processes
• Familiarity with applicable standards and regulations (e.g., ISO, EN, AAMI)
• Experience conducting or supporting investigations, test method development, and validation
• Knowledge of regulatory and quality requirements related to suppliers and external manufacturing
• Experience supporting audits, inspections, or compliance assessments
• Strong communication and collaboration skills, with the ability to work across functions and levels
• Ability to work independently while contributing effectively to team objectives
• Fluent in English (French and/or German are a plus)
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

Benefits

We offer a collaborative environment where we work together to ensure high standards in microbiological quality and sterility assurance across a global supply network. This role provides opportunities to develop expertise, work with external partners, and contribute to continuous improvement.

Additional Role Information

This role may involve working in controlled environments (e.g., cleanrooms) and requires appropriate gowning practices where applicable. The position includes regular interaction with suppliers and external partners, as well as participation in audits and inspections. Travel within EMEA is expected (approximately 20-30%).

We are an equal opportunity employer and value diversity in our workforce. We welcome applications from people of all backgrounds, experiences, and perspectives. If reasonable accommodation is needed during the recruitment process or while performing the role, support is available at every stage - please let us know how we can help.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).