Sterility & Aseptic Assurance Expert (F/M)

The Automation Partnership (Cambridge); Illkirch-Graffenstaden; On-site; EUR 90,000 - 120,000; Full time

Job summary

The Automation Partnership (Cambridge) is seeking a Sterility & Aseptic Assurance Expert to safeguard sterile and aseptically processed products. You will apply expertise in sterility assurance, contamination control, microbiology, aseptic processing, and sterilization validation to support compliant manufacturing.

Based in Illkirch (67), you will collaborate with cross-functional teams to strengthen quality programs and resolve complex contamination events while upholding regulatory

Qualifications

• Bachelor's degree in Microbiology, Biology, Biotechnology, Life Sciences, Engineering, Quality Management, or related field.
• 5+ years in Sterility Assurance, Microbiology, Contamination Control, Sterilization Validation, or related Quality roles in regulated environments.
• Proven expertise in sterility and contamination testing and complex event resolution.

Responsibilities

• Strengthen sterility assurance & contamination control programs by implementing contamination control, aseptic processing, and sterilization validation strategies through assessment of weaknesses in microbiological controls and execution risks to prevent contamination-related product quality failures
• Optimize microbiological, endotoxin, subvisible particulate, and sterility testing activities across laboratories & manufacturing sites by providing expertise in method validation, method transfer, troubleshooting, result interpretation, and lifecycle management of analytical methods to protect product release eligibility
• Enable resolution of major sterility and contamination events by contributing specialist expertise to investigations, root cause analysis, containment, remediation, and recovery activities to minimize manufacturing downtime
• Develop and deploy practical sterility assurance standards, contamination control practices, and aseptic processing guidance by translating regulatory expectations, industry practices, operational experience, and lessons learned into site implementation support to preserve authorization to manufacture sterile and aseptically processed products

Skills

Sterility Assurance

Microbiology

Contamination Control

Aseptic Processing

Sterilization Validation

Quality Management

Problem-solving

English fluency

Education

Bachelor's degree in Microbiology or Life Sciences

Job description

Join our Operational Quality Assurance team as a Sterility & Aseptic Assurance Expert (F/M) and play a key role in providing specialized expertise in sterility assurance, contamination control, microbiology, aseptic processing, and sterilization validation to protect the availability of compliant sterile and aseptically processed products. Through your contribution to reliable manufacturing output, you will help our teams focus on what matters most: better health for more people.

Based in Illkirch (67), you will become part of a team of dedicated professionals who look forward to shaping the future together with you.

Grow with us - Your Responsibilities

• Strengthen sterility assurance & contamination control programs by implementing contamination control, aseptic processing, and sterilization validation strategies through assessment of weaknesses in microbiological controls and execution risks to prevent contamination-related product quality failures
• Optimize microbiological, endotoxin, subvisible particulate, and sterility testing activities across laboratories & manufacturing sites by providing expertise in method validation, method transfer, troubleshooting, result interpretation, and lifecycle management of analytical methods to protect product release eligibility
• Enable resolution of major sterility and contamination events by contributing specialist expertise to investigations, root cause analysis, containment, remediation, and recovery activities to minimize manufacturing downtime
• Develop and deploy practical sterility assurance standards, contamination control practices, and aseptic processing guidance by translating regulatory expectations, industry practices, operational experience, and lessons learned into site implementation support to preserve authorization to manufacture sterile and aseptically processed products

What will convince us

• 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 support of audits and regulatory inspections
• Proven expertise in sterility assurance, contamination control, microbiological, endotoxin, subvisible particulate testing, and complex sterility event resolution
• Strong problem-solving, facilitation, and influencing skills across Manufacturing, Site Quality, Laboratories, and Global Quality functions
• Fluent in English

About Sartorius

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

www.sartorius.com/careers