Principal Scientist- Med Device Mircobiology
About The Position
Eurofins Scientific is an international life sciences company providing a unique range of analytical testing services. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. This role will serve as a technical subject matter expert and resource for internal and external audits, client interactions, and business development activities. The Principal Scientist will provide scientific leadership and guidance on medical device reprocessing and microbiology testing programs. They will support method development, validation, troubleshooting, and continuous improvement initiatives. The role requires communicating complex technical information effectively to clients, regulatory bodies, and internal stakeholders.
Requirements
- Extensive experience in medical device reprocessing, including cleaning, disinfection, and sterilization processes.
- Strong background in microbiological testing, including antimicrobial efficacy, sterility, sub-visible particle analysis, bioburden, microbial limits testing (MLT), container closure integrity testing (CCIT), and endotoxin testing, with recognized subject matter expertise in at least one testing discipline.
- Experience working in controlled environments and cleanroom operations.
- Comprehensive understanding of the medical device lifecycle, from development through commercialization and post-market support.
- Demonstrated expertise in designing, executing, and evaluating scientific studies and test methods.
- Proven ability to interpret pharmacopeial requirements, industry standards, and regulatory guidance documents, and assess emerging methodologies and technologies for applicability.
- Strong technical writing skills with experience authoring protocols, reports, investigations, and other scientific documentation.
- Bachelor’s degree in biology or microbiology
- Minimum 5 years of laboratory experience
- Working knowledge of Electronic Lab Notebook (ELN), Lab Information Management System (LIMS)
- Solid familiarity and experience with regulatory and accreditation standards (GMP, GLP, USP, ISO, AATCC, etc).
- Prior experience working in microbiology – especially antimicrobial and reprocessing
- Strong leadership
- Excellent planning, organizational, and multitasking skills.
- Strong technical writing skills including experience with investigations.
- Familiarity with Lean, Six Sigma, or similar process improvement methodologies
- Experience with onboarding new instrumentation, including performing/reviewing IQ/OQ/PQ data or qualifications
- Authorization to work in the US indefinitely without restriction or sponsorship
Nice To Haves
- Exceptional collaboration and interpersonal skills, with the ability to build strong partnerships and work effectively across cross-functional teams.
- Strong analytical, problem-solving, and decision-making abilities.
- Ability to influence stakeholders and provide technical leadership in a fast-paced, regulated environment.
Responsibilities
- Serve as a technical subject matter expert and resource for internal and external audits, client interactions, and business development activities.
- Provide scientific leadership and guidance on medical device reprocessing and microbiology testing programs.
- Support method development, validation, troubleshooting, and continuous improvement initiatives.
- Communicate complex technical information effectively to clients, regulatory bodies, and internal stakeholders.
Benefits
- Comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
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What This Job Offers
Job Type
Full-time
Career Level
Senior
