Sterility & Aseptic Assurance Specialist

The Automation Partnership (Cambridge); Illkirch-Graffenstaden; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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

Kenntnisse

Sterility Assurance

Microbiology

Contamination Control

Aseptic Processing

Sterilization Validation

Quality Management

Problem-solving

English fluency

Ausbildung

Bachelor's degree in Microbiology or Life Sciences

Jobbeschreibung

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