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.