Global Sterility Assurance Lead: Harmonize & Elevate

BioSpace; Indianapolis (IN); On-site; USD 114,000 - 198,000; Full time

Benefits offered by this job

Comprehensive benefit program

401(k) and pension

Flexible benefits packages

Job summary

A global healthcare leader in Indianapolis is seeking a Sr. Principal/Advisor in Sterility Assurance to oversee comprehensive sterility assurance initiatives. The role includes mentoring, providing technical support, and ensuring alignment with regulatory standards within the Parenteral Product Network. Ideal candidates will possess a scientific background and extensive experience in sterility assurance within regulated environments. This position requires strong communication and problem-solving skills. Competitive compensation offered.

Qualifications

• 5+ years’ experience in Parenteral Sterility Assurance or Microbiology.
• Experience in regulated environments with sterility assurance control systems.

Responsibilities

• Ensure sterility assurance strategies align with regulatory and compliance expectations.
• Support sterility assurance initiatives including quality standard development.
• Provide technical support during regulatory interactions and inspections.

Skills

Technical understanding of sterility assurance

Data analysis

Communication skills

Attention to detail

Problem-solving skills

Education

Bachelor's/Master's in biological science or engineering

Job description

A global healthcare leader in Indianapolis is seeking a Sr. Principal/Advisor in Sterility Assurance to oversee comprehensive sterility assurance initiatives. The role includes mentoring, providing technical support, and ensuring alignment with regulatory standards within the Parenteral Product Network. Ideal candidates will possess a scientific background and extensive experience in sterility assurance within regulated environments. This position requires strong communication and problem-solving skills. Competitive compensation offered.