Senior Microbiologist

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We are seeking an experienced and driven Senior Microbiologist to join our team. In this critical role, you will be responsible for ensuring the microbial compliance of our products in alignment with regulatory standards for medical devices.

The ideal candidate will have a strong background in microbiology and sterilization processes within a regulated industry. If you are relentless about quality, thrive in a fast-paced environment, and have a passion for driving continuous improvement, this role is for you.

Key Responsibilities:

• Ensure microbial compliance of products in accordance with relevant medical device regulatory standards.
• Oversee the validation, monitoring, and testing of cleaning, disinfection, and sterilization processes and associated utilities.
• Lead environmental monitoring of cleanrooms in compliance with ISO 14644, along with monitoring utilities, including water quality, compressed air, bioburden, and endotoxin testing.
• Interpret sampling and monitoring data, applying statistical analysis to ensure control and trend identification.
• Serve as a subject matter expert on internal and external regulatory requirements (FDA, ISO, MDD, etc.).
• Lead root cause analysis, non-conformance (NC) correction, and CAPA resolution within the microbiology team and related business units.
• Act as a technical lead for microbiology in cross-functional teams, addressing product and process issues, root cause analysis, and business-critical projects.
• Apply current Good Laboratory Practices (cGLP) to all microbiology-related activities, including stock control and laboratory compliance.
• Perform sterility testing, release reviews, and validations in line with BS EN ISO standards.
• Collaborate with Supplier Quality teams to manage vendor sterility topics.
• Continuously identify opportunities for process stabilization and cost-saving measures through trend analysis and statistical control.
• Develop and maintain technical documentation to ensure ongoing compliance.
• Mentor and train team members and cross-functional partners on microbiological standards and processes.

Qualifications:

• Bachelor's degree in Microbiology or a related discipline.
• Minimum of 6 years' experience as a Microbiologist in a regulated industry, specializing in cleaning, disinfection, biocompatibility, or sterilization.
• Strong competency in troubleshooting, root cause analysis, and correction of non-conformances (NC).
• Knowledge of regulatory standards for medical devices (FDA, ISO, MDD) and cGLP.
• Proven experience in leading cross-functional collaborations and building strong partnerships across teams.

Collaborative Partnership:

• Build and leverage cross-functional relationships to gather ideas, information, and best practices.
• Act as a subject matter expert in microbiology, providing guidance on product sterility, biocompatibility, and risk assessments.
• Support successful integration of new products into validated processes, ensuring compliance with sterile and non-sterile standards.

We celebrate the rich tapestry of backgrounds and perspectives that make us stronger as a team. Please note that only qualified individuals being considered will be contacted. We appreciate your interest and look forward to potentially embarking on a transformative journey together.

Job Title:
Senior Microbiologist - Medical Devices Specialist

Job Overview:
We are seeking an experienced and driven Senior Microbiologist to join our team.

In this critical role, you will be responsible for ensuring the microbial compliance of our products in alignment with regulatory standards for medical devices.

The ideal candidate will have a strong background in microbiology and sterilization processes within a regulated industry.

If you are relentless about quality, thrive in a fast-paced environment, and have a passion for driving continuous improvement, this role is for you.

Key Responsibilities:
Ensure microbial compliance of products in accordance with relevant medical device regulatory standards.
Oversee the validation, monitoring, and testing of cleaning, disinfection, and sterilization processes and associated utilities.

Lead environmental monitoring of cleanrooms in compliance with ISO 14644, along with monitoring utilities, including water quality, compressed air, bioburden, and endotoxin testing.

Interpret sampling and monitoring data, applying statistical analysis to ensure control and trend identification.

Serve as a subject matter expert on internal and external regulatory requirements (FDA, ISO, MDD, etc.).Lead root cause analysis, non-conformance (NC) correction, and CAPA resolution within the microbiology team and related business units.

Act as a technical lead for microbiology in cross-functional teams, addressing product and process issues, root cause analysis, and business-critical projects.

Apply current Good Laboratory Practices (cGLP) to all microbiology-related activities, including stock control and laboratory compliance.
Perform sterility testing, release reviews, and validations in line with BS EN ISO standards.
Collaborate with Supplier Quality teams to manage vendor sterility topics.
Continuously identify opportunities for process stabilization and cost-saving measures through trend analysis and statistical control.
Develop and maintain technical documentation to ensure ongoing compliance.
Mentor and train team members and cross-functional partners on microbiological standards and processes.

Qualifications:
Bachelor's degree in Microbiology or a related discipline.
Minimum of 6 years' experience as a Microbiologist in a regulated industry, specializing in cleaning, disinfection, biocompatibility, or sterilization.

Strong competency in troubleshooting, root cause analysis, and correction of non-conformances (NC).Knowledge of regulatory standards for medical devices (FDA, ISO, MDD) and cGLP.Proven experience in leading cross-functional collaborations and building strong partnerships across teams.

Ability to interpret complex data and drive comprehensive solutions that ensure ongoing compliance and process improvements.

Collaborative Partnership:
Build and leverage cross-functional relationships to gather ideas, information, and best practices.
Act as a subject matter expert in microbiology, providing guidance on product sterility, biocompatibility, and risk assessments.
Support successful integration of new products into validated processes, ensuring compliance with sterile and non-sterile standards.
If you are passionate about quality and microbial compliance, and eager to contribute to the development of innovative medical products, we encourage you to apply#LI-DR2

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