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Eurofins · 3 months ago

Senior Sterilization Engineer (Expert, Multiple Modalities)

Lancaster, PA, USA

Full-time

Onsite

Senior Level

7+ years exp

Eurofins Scientific is an international life sciences company that provides a unique range of analytical testing services to various industries. They are seeking a Senior Sterilization Engineer to lead validation and sterility assurance systems, ensuring compliance with regulatory standards and mentoring colleagues in sterilization practices.

BiotechnologyGeneticsHealth CareLife SciencePharmaceutical

Responsibilities

Lead sterilization strategy and validation for two or more modalities: e.g. EtO, gamma/X‑ray, e‑beam, 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 technologies—delivering 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)

Qualification

Sterilization methodsISO sterilization standardsSterility assurance systemsRegulatory complianceTechnical certificationClient engagementAnalytical problem-solvingMicrosoft Office proficiencyCommunication skillsMentorship experience

Required

Bachelor's degree in engineering (Mechanical, Chemical, Biomedical), Microbiology, Chemistry, or a related scientific discipline

Minimum 7–10+ 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/X‑ray, or VHP + steam) with hands-on experience in process development and validation

In‑depth 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 risk‑based 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

Expert-level technical and analytical problem‑solving capabilities

Strong communication skills—capable of translating sterilization standards into actionable protocols and delivering them to cross‑functional 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