Senior Sterilization Engineer (Expert, Multiple Modalities) at Eurofins

Lancaster, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Jan, 26

Salary

0.0

Posted On

21 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Sterilization Engineering, Validation, Regulatory Compliance, Material Compatibility, Bioburden Monitoring, Environmental Monitoring, ISO Standards, Technical Guidance, Client Engagement, Cleanroom Validation, Packaging Validation, Risk-Based Evaluation, Audit Readiness, Mentorship, Communication Skills, Data-Driven

Industry

Medical and Diagnostic Laboratories

Description

Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description 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. You’ll 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/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). Qualifications Education Bachelor’s degree in engineering (Mechanical, Chemical, Biomedical), Microbiology, Chemistry, or a related scientific discipline (Master’s preferred). Experience 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. 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. Competencies 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. 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.

Responsibilities

Lead sterilization strategy and validation for multiple modalities while ensuring compliance with relevant standards and regulations. Mentor internal colleagues and clients, significantly influencing client engagement and shaping sterilization excellence across the organization.