Senior EO Sterility Assurance Lead – Remote/APAC

Avighna Quality Consulting Services; United States; Remote; USD 200,000 - 260,000; Full time

Benefits offered by this job

Travel to client sites

Remote work

Support from AVIGHNA QA Consulting

Job summary

AVIGHNA QA Consulting Pvt Ltd seeks a Sterilization Manager to lead EO sterilization and contamination control for a high-precision medical device contract manufacturer. You will own EO processes, validate and requalify cycles, and ensure compliance to ISO 11135, 10993-7, and ISO 14644 across the site.

You will head the sterility assurance program, oversee environmental and personnel monitoring, guide QA leadership, and drive audits with FDA/Notified Bodies while mentoring the local team.

Qualifications

• Must have overall 20+ years in medical device sterilization, microbiology and quality.
• Hands-on EO sterilization operation and validation to ISO 11135.
• Proven record resolving bioburden issues and running bioburden programs to ISO 11737.
• Direct oversight of aseptic-area EM (VPC/NVPC) and personnel monitoring.
• Front-line audit/inspection experience with US FDA or Notified Bodies.

Responsibilities

• EO sterilization: operate, monitor, troubleshoot cycles and review records.
• Bioburden and product microbiology: investigate excursions and oversee testing.
• Aseptic operations and environmental monitoring: manage EM program and personnel monitoring.
• Aseptic personnel qualification: train and qualify aseptic-entry personnel.
• Quality system, compliance and leadership: lead audits, CAPAs and changes; align with standards.

Skills

Sterilization leadership

Bioburden analysis

Environmental monitoring

Regulatory audits

ISO 13485 knowledge

English communication

Education

Microbiology degree

Master's or PhD preferred

Job description

AVIGHNA QA Consulting Pvt Ltd seeks a Sterilization Manager to lead EO sterilization and contamination control for a high-precision medical device contract manufacturer. You will own EO processes, validate and requalify cycles, and ensure compliance to ISO 11135, 10993-7, and ISO 14644 across the site.

You will head the sterility assurance program, oversee environmental and personnel monitoring, guide QA leadership, and drive audits with FDA/Notified Bodies while mentoring the local team.