Principal Scientist- Med Device Mircobiology

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.

Qualifications :

Minimum Qualifications

• Bachelors 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

Additional Information :

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.

Remote Work :

No

Employment Type :

Full-time