Senior Sterility & Aseptic Assurance Specialist

Sartorius; Illkirch-Graffenstaden; On-site; EUR 85,000 - 110,000; Full time

Job summary

Sartorius in Illkirch-Graffenstaden, France, seeks an experienced Sterility & Aseptic Assurance Expert to strengthen its Operational Quality Assurance efforts. You will support sterility, contamination control, and aseptic processing, ensuring robust microbiology practices and validated sterilization methods across sites.

The role emphasizes investigations, root cause analyses, and cross-functional collaboration with Manufacturing, Site Quality, and Global Quality teams.

Qualifications

• Bachelor's degree in Microbiology, Biology, Biotechnology, Life Sciences, Engineering, Quality Management, or related field.
• 5+ years of experience in Sterility Assurance, Microbiology, Contamination Control, Sterilization Validation, Aseptic Processing, or related Quality roles in regulated manufacturing environments, including audits/regulatory inspections
• Fluent in English and strong problem-solving, facilitation, and influencing skills

Responsibilities

• Strengthen sterility assurance and contamination control programs by implementing strategies and assessing microbiological risks to prevent contamination-related failures
• Optimize microbiological, endotoxin, subvisible particulate, and sterility testing across laboratories and sites through method validation, transfer, troubleshooting, and lifecycle management
• Enable resolution of major sterility events by investigations, root cause analysis, containment, remediation, and recovery activities to minimize downtime
• Develop and deploy sterilization/aseptic processing guidance by translating regulatory expectations into site implementation

Skills

Sterility assurance

Microbiology

Contamination control

Aseptic processing

Sterilization validation

Problem-solving

Facilitation

Influencing

English fluency

Education

Bachelor's degree in Microbiology or related field

Job description

Sartorius in Illkirch-Graffenstaden, France, seeks an experienced Sterility & Aseptic Assurance Expert to strengthen its Operational Quality Assurance efforts. You will support sterility, contamination control, and aseptic processing, ensuring robust microbiology practices and validated sterilization methods across sites.

The role emphasizes investigations, root cause analyses, and cross-functional collaboration with Manufacturing, Site Quality, and Global Quality teams.