Sterility Assurance Leader — Senior QA & Aseptic Expert

ThermoFisher Scientific; Seneffe; On-site; EUR 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Senior QA Sterility Assurance SME to act as the site champion for sterility, contamination control and environmental monitoring on a multi-product biopharma site.

You will partner with Manufacturing, Quality Control and Engineering to strengthen aseptic standards, define CCS and PQEM-related activities, and ensure GMP compliance while supporting audits and continuous improvement across site functions.

Qualifications

• Master's Degree or equivalent university education in Biology, Biochemistry, Chemistry or a related scientific discipline.
• Minimum of 10 years of relevant experience within the pharmaceutical industry.
• Minimum 3 years of experience in a pharmaceutical manufacturing environment (QA culture), preferably aseptic manufacturing.
• Strong expertise in Sterility Assurance, aseptic processing and contamination control principles.
• Fluency in French and English, both written and spoken are a must.
• Demonstrated ability to coach, train and explain complex technical and scientific concepts to diverse audiences.

Responsibilities

• Act as the site's Sterility Assurance Lead and subject matter expert, providing technical leadership and decision-making.
• Develop strategies to strengthen the site's Sterility Assurance culture and aseptic manufacturing standards.
• Escalate major Sterility Assurance events to the Site Quality Head and coordinate remediation plans.
• Develop, maintain and oversee the site's Contamination Control Strategy (CCS) and related documents.
• Lead execution of the site's Aseptic Improvement Plan in partnership with Manufacturing.
• Review and approve aseptic process simulation strategies and PQEM activities.

Skills

Sterility Assurance

Aseptic Processing

Contamination Control

Technical Writing

Cross-functional Collaboration

Regulatory & GMP Knowledge

Education

Master's Degree in Biology/BioChemistry/C Chemistry or related discipline

Job description

Thermo Fisher Scientific is seeking a Senior QA Sterility Assurance SME to act as the site champion for sterility, contamination control and environmental monitoring on a multi-product biopharma site.

You will partner with Manufacturing, Quality Control and Engineering to strengthen aseptic standards, define CCS and PQEM-related activities, and ensure GMP compliance while supporting audits and continuous improvement across site functions.