About the Role

As a Senior Microbiologist, you will be responsible for conducting routine and non-routine microbiological testing to ensure sterility assurance for medical devices. Your tasks will include performing bioburden, sterility, and bacterial endotoxin testing, supporting environmental monitoring programs, and ensuring compliance with laboratory quality standards. You will also contribute to quality system integration and collaborate with cross-functional teams to assess microbial risks and implement corrective actions.

About You

Required:

5+ years of experience in the medical device industry with a strong background in microbiology laboratory processes.
Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
Outstanding communication and interpersonal skills.
Proficiency in Microsoft Office Suite and quality management systems (QMS).
Strong technical writing capability.
Experience with Bioburden, Sterility, Bacterial Endotoxin testing, and Cleanroom environmental monitoring.

Preferred:

In-depth knowledge and testing experience with ISO 11737-1, ISO 11737-2, ISO 11737-3, and environmental monitoring tests.
Working knowledge of sterilization standards ISO 11137-1, ISO 17665, ISO 11135.
Experience in a quality control focused Microbiology lab environment (ISO 17025).

Founded in 2012, Planet Pharma has a dedicated team of seasoned professionals with extensive experience supporting the Life Sciences industry, specifically: - Pharmaceuticals - Biotechnology - Medical Device & Diagnostics - Clinical Research Organizations (CROs) - CMOs / CDMOs - Specialty Providers - Labs & Healthcare Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent — ultimately making staffing more personal and creating enduring, valuable relationships. We achieve this by leveraging cutting-edge technology and flexible service delivery models that enable us to provide personalized solutions for your business. Planet Pharma has offices throughout North America, Europe, and APAC. All locations operate with shared attributes at the heart of everything we do! We provide the following solutions: - Contract & Direct Hire (Permanent) Staffing - Strategic Resourcing - Retained & Executive Search - Functional Service Provider (FSP) - Global Workforce Solutions

Senior Microbiologist

Highlight

Summary

About the Role

About You

Benefits