Sterilization & Biocompatibility SME

SRG is seeking a Sterilization & Biocompatibility Subject Matter Expert (SME) to support the development, validation, and qualification of a cell therapy delivery device. This role will be heavily focused on sterilization strategy and validation, with additional responsibility supporting biocompatibility strategy and interpretation.

This is a remote, project-based engagement, beginning part-time with expected ramp-up to full-time as the program progresses.

Key Responsibilities

• Lead sterilization development and validation activities with a primary focus on Ethylene Oxide (EO) and evaluation of alternative modalities (primarily E-beam)
• Support ongoing device design changes, including assessment of impact to sterilization strategy and potential revalidation efforts
• Author and review validation protocols and reports (hands-on responsibility required)
• Design, execute, and interpret sterilization validation studies
• Evaluate and optimize sterilization processes as the program evolves
• Develop and/or refine biocompatibility strategy aligned with ISO 10993 standards
• Interpret biocompatibility data and contribute to biological risk assessments
• Collaborate cross-functionally with Process Engineering, Quality, and Regulatory teams
• Provide SME guidance across technical reviews within a multi-disciplinary team

Required Qualifications

• 7+ years of hands-on experience in medical device sterilization and validation
• Strong expertise in Ethylene Oxide (EO) sterilization with experience evaluating or working with E-beam (Gamma/X-ray exposure a plus, but not required)
• Proven experience authoring sterilization validation protocols and reports (hands-on execution required - not oversight only)
• Strong knowledge of industrial sterilization modalities and validation approaches
• Experience supporting design changes and associated sterilization revalidation
• Medical device industry experience is required
• Background in microbiology and cleanroom control environments
• Experience with bioburden testing and endotoxin (LAL) testing
• Working knowledge of biocompatibility standards (ISO 10993 series) with ability to:
  • Develop strategy
  • Interpret data
  • Contribute to or lead biological risk assessments

Preferred Qualifications

• Experience supporting combination products, complex devices, or cell therapy delivery systems
• Ability to independently own biological risk assessments
• Experience building or re-establishing biocompatibility strategy from early or changing design stages

Additional Information

SRG values your application, and our team will be in touch with candidates moving forward in the process.