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    Eurofins

    Life Sciences

    Principal Scientist- Med Device Mircobiology

    Lancaster, United StatesOn-SiteFull-timePosted 4d ago
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    Job description

    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.

    Job details are sourced from the employer's original posting.

    Open job posting
    EU

    About the company

    Eurofins

    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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. Eurofins PSS Insourcing has an exciting and rewarding opportunity for a Business Development Manager to join our team.  We are searching for a business development professional with proven experience selling and implementing high-value sales.  Someone who thrives on identifying and closing new business caring for the client through the process will succeed in this role. This position offers the excitement of hunting for new clients with the goal of diversifying our offerings and client base as well as the opportunity to foster and expand partnerships with key clients.  This is a hybrid role working remotely from a home office, travelling locally and within the region for prospect and current client meetings as well as full days spent at current client sites to maximize networking and relationship building opportunities. A successful candidate will have a proven track record and is comfortable reaching out to and meeting with high level decision makers including C-Suite.  This position will manage the strategic sales process including identifying client needs, defining and presenting how PSS can address them, as well as managing the implementation process for new programs. If you’re looking for a rewarding career, a place to call home, apply with us today! 

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    Life Sciences
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