Sterility Assurance Advisor

Your Role

As Sterility Assurance & Contamination Control Strategy, you will serve as the site’s technical authority for contamination control and sterility assurance, ensuring alignment with global quality standards and regulatory expectations.

Responsibilities

• Lead the design, implementation, and continuous evolution of the site-wide Contamination Control Strategy (CCS)
• Provide technical oversight and strategic direction for aseptic, process, and sterilization validation programs
• Lead investigations and resolution of contamination events, sterility failures, deviations, and CAPAs
• Represent and defend sterility assurance programs during regulatory inspections and corporate audits
• Mentor and develop technical talent while driving scientific rigor and risk-based decision-making across the organization

Requirements

• Education: Bachelor’s degree in microbiology, Biology, or related scientific field; advanced degree preferred
• Experience: Minimum 8+ years of experience in sterile manufacturing, biotechnology, or related regulated environments
• Top 2 skills: Deep expertise in aseptic processing and sterility assurance combined with proven ability to influence complex technical issues and regulatory interactions

Preferred Qualifications

• Master’s or PhD in Microbiology, Immunology, or related biological science
• Experience with virus production in cell monolayers, bioreactors, or fermenters
• Strong knowledge of microbial ecology and sterile manufacturing environments
• Experience with EU GMP Annex 1 requirements and implementation of CCS programs
• Experience leading large-scale quality, validation, or contamination control initiatives across regulated environments