Sterilization & Biocompatibility SME - Medical Device/EO

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.

• 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
  
  

• 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
    
    

• 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
  
  

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

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.