Senior Global Quality Engineer - Sterilization
Listed on 2026-09-07
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.
Senior Global Quality Engineer- Sterilization
Regular
- Full Time Camarillo, CA, US
Salary Range: $ To $ Annually
About Sani Sure
Sani Sure 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, Sani Sure 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 Sani Sure'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
- Lead gamma sterilization validations (IQ/OQ/PQ) including dose mapping, dose setting/establishment (VDmax
25, 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
- 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…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).