Cleaning & Sterilization Validation Specialist

Become a Cleaning & Sterilization Validation Specialist at Highridge Medical.

Cleaning & Sterilization Validation Specialist

$81,156 – $106,517 per year

Seeking a highly skilled Quality Assurance Specialist with a strong scientific background to lead the manufacturing cleaning and terminal sterilization programs for the Highridge Medical product lines. Under the direction of the department manager, the team member will work closely with the R&D and Operations teams to ensure the manufacturing cleaning of implants and instruments and sterilization of terminally sterilized products meet all regulatory and product safety requirements.

• Experience with manufacturing cleaning and sterilization per FDA, EU MDD, EU MDR and ISO requirements (e.g. ISO
  19227, ISO
  11137, ISO
  11737, ST79, ST98).
• Apply chemistry principles to evaluate cleaning agents, residue removal, and material compatibility.
• Conduct residue analysis, bioburden testing, and endotoxin assessments in collaboration with microbiology and analytical labs.
• Troubleshoot and optimize cleaning and sterilization processes using root‑cause analysis and risk‑based approaches.
• Support sterilization requalification and radiation dose audit programs to ensure continuity of validated processes.
• Coordinate validations and process monitoring for the manufacturing cleaning program across company vendors and gamma sterilization of terminally sterilized products. Include bioburden testing, sterility testing, inorganic and organic residuals, cytotoxicity, and endotoxin testing.
• Work closely with R&D, Manufacturing, Quality Assurance, and Regulatory Affairs to support new product development and lifecycle management.
• Provide technical training and guidance to production and quality teams on cleaning and sterilization procedures.
• Author and revise SOPs and risk‑based rationales using the electronic quality management system.

• Maintenance and data entry in the Contact Material Database.
• Research contact material safety and ingredients for developing contact material families.

• Strong communication skills for interactions with internal and external customers.
• Ability to work independently with some supervision and drive projects forward.
• Adaptability to a variety of projects and shifting priorities.
• Prioritization, organization, and planning skills to meet due dates and communicate obstacles promptly.
• Computer skills:
  Windows, MS Office with a focus on Excel and Word.

• Bachelor’s or Master’s degree in Chemistry, Chemical Engineering, Microbiology, or related field.
• 3+ years of experience or equivalent combination of education and experience in medical device, biotechnology, or pharmaceutical field.

Occasional travel up to 20%.

• Medical insurance
• Vision insurance
• 401(k)