Eurofins BioPharma Product Testing North America · 1 month ago
Senior Sterilization Engineer (Expert, Multiple Modalities)
Lancaster, PA
Full-time
Onsite
Senior Level
7+ years expEurofins Scientific is an international life sciences company providing a unique range of analytical testing services. They are seeking a technical expert in sterilization to lead validation and sterility assurance systems from R&D through commercial scale, overseeing sterilization validation programs and ensuring regulatory compliance.
Biotechnology
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
Required
Bachelor's degree in engineering (Mechanical, Chemical, Biomedical), Microbiology, Chemistry, or a related scientific discipline (Master's preferred)
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
Preferred
Technical certification such as Certified Industrial Sterilization Specialist (CISS–EO or CISS radiation) is strongly preferred
Management or mentorship or consulting experience is a plus
Benefits
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
Company
Eurofins BioPharma Product Testing North America
Eurofins BioPharma Product Testing is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide providing comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase