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About SaniSure
SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today's most innovative and life-changing medicines.
As we continue to expand our product offerings and global footprint, SaniSure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry.
Job Summary
The Senior Global Quality Engineer – Sterilization is a subject matter expert responsible for the technical oversight, validation, and lifecycle management of gamma irradiation sterilization processes for SaniSure's products across a global manufacturing and supply network. This role ensures sterilization processes remain compliant with applicable international standards (ISO 11137, ISO 13485, ISO 14937, 21 CFR 820/210/211) and supports new product introductions, sterilization dose audits, supplier/contract sterilizer qualification, and continuous improvement initiatives.
Essential Functions
Sterilization Process Ownership & Validation
- Lead gamma sterilization validations (IQ/OQ/PQ) including dose mapping, dose setting/establishment (VDmax25, Method 1, Method 2 per ISO 11137-2), and product family bracketing
- Serve as the technical authority for gamma sterilization process design, transfer, and revalidation activities across global manufacturing sites and contract sterilization partners
- Own and maintain sterilization dose audit programs, ensuring timely execution, trend analysis, and corrective actions for non-conformances
- Evaluate bioburden data, product family groupings, and material compatibility to support sterility assurance level (SAL) justification
Regulatory & Standards Compliance
- Ensure sterilization processes and documentation comply with ISO 11137 (parts 1–3), ISO 11737 (bioburden/sterility testing), ISO 13485, ISO 14937, and relevant FDA/EU requirements
- Support customer regulatory submissions (510(k), PMA, Technical Files/Design Dossiers) with sterilization validation data and technical rationale
- Represent the organization during audits (Customer, Notified Body) and customer/contract sterilizer audits as the sterilization subject matter expert
- Monitor evolving global sterilization regulations and standards, assessing impact and driving organizational readiness
Supplier & Contract Sterilizer Management
- Qualify, audit, and manage relationships with contract sterilization providers globally
- Review and approve supplier validation protocols, dosimetry reports, and change notifications
- Drive resolution of sterilization-related supplier quality issues, deviations, and CAPAs
Change Control, Risk & Continuous Improvement
- Assess and approve engineering changes (material, packaging, product design) for sterilization impact
- Lead risk assessments (FMEA) related to sterilization processes and product sterility assurance
- Drive standardization of sterilization validation practices, templates, and best practices across global sites
- Investigate sterilization-related nonconformances, deviations, and complaints; lead root cause analysis and CAPA implementation
Cross-Functional Leadership
- Partner with R&D, Regulatory Affairs, Operations, and Supply Chain on new product development and product transfers
- Mentor junior quality/sterilization engineers and provide training on sterilization principles and standards
- Present sterilization program status, metrics, and risks to senior leadership and quality management review boards
Design Quality Assurance
- Serve as the Quality representative on cross-functional new product development (NPD) teams, ensuring design control requirements are met throughout the product lifecycle
- Author, review, and approve design control deliverables including design inputs/outputs, risk management files (per ISO 14971), design verification/validation protocols and reports, and design history files (DHF)
- Lead or support Failure Mode and Effects Analyses (dFMEA)
- Support design transfer activities, ensuring manufacturing processes are robust and capable of consistently producing product that meets specifications
- Review and approve engineering changes and assess impact on product quality and validated states
- Support root cause investigations, CAPA, and nonconformance activities tied to design or process issues
- Perform other duties as assigned
Education / Certifications
- Bachelor's degree in biological sciences, engineering, or a related field.
Required Experience & Competencies
Education & Experience
- Bachelor's degree in Engineering, Microbiology, Biomedical Sciences, or related technical field (advanced degree a plus)
- 5–10 years of experience in quality/sterilization engineering within medical device or pharmaceutical manufacturing
- Demonstrated hands-on expertise specifically in gamma irradiation sterilization — dose mapping, dose audits, dose establishment methods (VDmax25, Method 1, Method 2, Method C1)
- Strong working knowledge of ISO 11137-1/-2/-3, ISO 11737-1/-2, ISO 14937, ISO 13485, and applicable FDA (21 CFR 820) and EU MDR requirements
- Experience with contract sterilizer qualification and management (e.g., Sterigenics, Steris, BeamOne, or equivalent)
- Proven experience supporting customer/notified body audits and inspections
- Strong statistical and technical writing skills for validation protocols/reports
- Experience with risk management tools (FMEA) and CAPA/root cause methodologies
Preferred Qualifications
- Experience with additional sterilization modalities (EtO, e-beam, X-ray, steam) for cross-modality perspective
- Global/multi-site quality experience across regions with differing regulatory frameworks (US, EU, APAC)
- Six Sigma / Lean certification
- Certified Quality Engineer (CQE) or equivalent certification
- Experience with bioburden testing methodologies and microbiology lab oversight
- Physical/Other Requirements: Ability to travel up to 10–15% (site visits, sterilization vendor audits)
Equal Employment Opportunity Policy
We are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion (including religious dress and grooming practices), color, sex (including childbirth, breast feeding, and related medical conditions), gender identity or expression, sexual orientation, national origin, citizenship status, uniform service member status, pregnancy, age (40 and over), genetic information, disability (mental and physical), or any other protected status in accordance with all applicable federal, state, and local laws.
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