Sterility Assurance Lead

!Come Work With Me – I'm Hiring a Sterility Assurance Lead

About the Role

We are looking for an experienced Sterility Assurance Lead to serve as the site's technical authority for sterility assurance, aseptic processing, and contamination control. This is a senior role within the Quality organization with direct impact on patient safety, product quality, and FDA inspection readiness.

Key Responsibilities

Lead and continuously improve the site Sterility Assurance Program and Contamination Control Strategy (CCS)

Serve as site SME for sterility assurance, aseptic processing, and contamination control

Provide expert oversight of aseptic manufacturing and filling operations

Lead EM/PM trending, excursion investigations, and contamination root cause analysis

Support media fill strategy, execution, and investigation

Assess aseptic practices, cleanroom behavior, and contamination risks

Support sterility assurance–related deviations, CAPA, change controls, and risk assessments

Oversee cleaning and disinfection effectiveness

Support FDA and global regulatory inspection readiness

Education:

B.Sc. in Microbiology, Biology, Biotechnology, Pharmacy, Biochemistry, Chemical Engineering, or a related life science discipline

M.Sc. / PhD – preferred

Experience:

5–7+ years in sterile pharmaceutical manufacturing, aseptic processing, QA sterile operations, or sterility assurance

Hands-on GMP experience with aseptic operations, contamination control, environmental monitoring, media fills, deviations, investigations, and regulatory inspections

FDA / EMA inspection experience – highly preferred

Send your CV to: [email protected]

Please note: This is a full-time on-site position based in Petah Tikva, Israel. Full remote work and relocation sponsorship are not available.