Principal Scientist- Med Device Mircobiology

Eurofins-USA-Medical-Device; Lancaster (Lancaster County); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA Medical Devices seeks a Principal Scientist in Lancaster, PA to lead microbiology testing programs and reprocessing activities for medical devices. You will guide method development, validation, and investigations, ensuring compliance with regulatory standards and quality systems.

The role requires extensive microbiology expertise, strong leadership, and excellent technical writing skills, with travel up to 25% as needed.

Qualifications

• Bachelor’s degree in biology or microbiology.
• Minimum 5 years of laboratory experience.
• Working knowledge of ELN and LIMS.
• Familiarity with GMP, GLP, USP, ISO, and related standards.
• Experience in microbiology – antimicrobial and reprocessing preferred.
• Authorization to work in the US indefinitely without sponsorship.

Responsibilities

• Serve as a technical SME for internal/external audits, client interactions, and business development activities.
• Provide scientific leadership on medical device reprocessing and microbiology testing programs.
• Support method development, validation, troubleshooting, and continuous improvement.
• Communicate complex technical information to clients, regulatory bodies, and internal stakeholders.

Skills

Team collaboration

Analytical thinking

Leadership

Technical writing

Project planning

Education

Bachelor’s degree in biology or microbiology

Tools

ELN

LIMS

Job description

Principal Scientist- Med Device Mircobiology

• Full-time

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.

Key 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.

Core Competencies

• 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.

Required Experience

• 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.

Minimum Qualifications

• 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

Position is full-time position, Monday - Friday 8:00am - 5:00pm with additional hours as needed. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply. Up to 25% travel may be required.

Excellent full time benefits including

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA Medical Devices is a Disabled and Veteran Equal Employment Opportunity employer.