Senior Sterilization Engineer (Expert, Multiple Modalities)

Eurofins Medical Device seeks a technical expert in sterilization to lead validation and sterility assurance systems from R&D through commercial scale at our Lancaster PA headquarters. Youll oversee sterilization validation programs (especially across two or more modalities) ensure regulatory compliance consult on packaging and material compatibility and mentor both internal colleagues and our facility in San Jose CA as well as Eurofins clients. Your role will significantly influence client engagement and help shape sterilization excellence across the organization.

Key Responsibilities

• Lead sterilization strategy and validation for two or more modalities: e.g. EtO gamma/Xray ebeam steam VHP or dry heat ensuring compliance with ISO 11135 ISO 11137 ISO 14937 ISO 17665 ISO 11737 and relevant regulations (ISO 13485 FDA QSR cGMP/GLP/GDP).
• Develop and manage IQ/OQ/PQ protocols for sterilization and sterile packaging validations.
• Evaluate material compatibility and define sterile packaging strategies effective across selected sterilization modalities. Assist in identifying testing required.
• Act as Subject Matter Expert for at least two sterilization technologiesdelivering technical guidance driving EO regulatory compliance and liaising across teams and external partners.
• Support bioburden and environmental monitoring programs in cleanroom environments (ISO 14644; ISO 11737). Advise clients on interrelations of the sterilization development and process including validations testing change evaluations etc.
• Develop and support cleanroom validation methodologies and environmental monitoring programs.
• Lead client engagement to define validation plans for complex or hard-to-sterilize products including new product development support.
• Support regulatory matters including EPA NESHAP TRI and state reporting in an expert capacity support San Jose site.
• Participate in internal/external audits; support CAPAs change controls and continuous improvement initiatives.
• Mentor and train staff and colleagues on sterilization theory validation best practices and operational excellence.
• Represent Eurofins in technical reviews client meetings and industry forums (e.g. AAMI EOSA).

Qualifications :

Education

• Bachelors degree in engineering (Mechanical Chemical Biomedical) Microbiology Chemistry or a related scientific discipline (Masters preferred).

Experience

• Minimum 710 years in sterilization engineering or sterile product validation ideally within medical device or pharmaceutical industries.
• Proven depth in at least two sterilization methods (e.g. EtO gamma/Xray or VHP steam) with hands-on experience in process development and validation.
• Indepth knowledge of ISO sterilization standards: ISO 11135 ISO 11137 ISO 17665 ISO 14937 ISO 11737.
• Experience with sterility assurance systems laboratory testing (sterility suitability bioburden testing etc.) packaging validation and riskbased evaluation for material compatibility.
• Familiarity with bioburden/ environmental monitoring programs.
• Experience with regulatory filings and audit readiness including EO reporting (EPA/NESHAP) FDA and ISO QMS expectations.
• Technical certification such as Certified Industrial Sterilization Specialist (CISSEO or CISS radiation) is strongly preferred.
• Management or mentorship or consulting experience is a plus.

Competencies

• Expert-level technical and analytical problemsolving capabilities.
• Strong communication skillscapable of translating sterilization standards into actionable protocols and delivering them to crossfunctional teams and clients.
• Proficient in Microsoft Office (Excel Word) DOE/statistical tools (e.g. Minitab) Lean/Six Sigma familiarity.
• Highly organized detail-oriented proactive and data-driven.

Additional Information :

Position is full-time Monday - Friday 8:00am - 5:00pm.  Candidates currently living within a commutable distance of Lancaster PA are encouraged to apply.

• 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 BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time