Sterility Assurance Senior (Pharmaceutical)

TL;DR

Sterility Assurance Senior (Pharmaceutical): Managing the sterility assurance risk profile and contamination control strategy for pharmaceutical manufacturing with an accent on GMP compliance and microbiological risk mitigation. Focus on optimizing aseptic processes, driving CAPA through data analysis, and ensuring regulatory compliance during inspections.

Location: Onsite in Belgium

Company

hirify.global is an independent technology consulting firm providing guidance and solutions across Information Systems, Telecom, Life Sciences, and Engineering.

What you will do

• Own the sterility assurance risk profile and implement the MU's Contamination Control Strategy.
• Monitor manufacturing processes to identify contamination sources and drive CAPA through facility design and risk assessments.
• Interpret microbiological data and trends to provide holistic recommendations for process improvements.
• Ensure full compliance with cGMP, internal QMS policies, and international regulatory standards.
• Act as the front-room representative during regulatory and corporate inspections.
• Provide coaching and training to teams on aseptic techniques and sterility assurance.

Requirements

• Location: Must be based in Belgium.
• Bachelor’s or Master’s degree in Microbiology, Pharmacy, Biology, or Biochemical Engineering.
• At least 5 years of professional experience in pharmaceutical manufacturing of sterile drugs or vaccines.
• Strong expertise in cGMP for biological products and sterility assurance.
• Languages: Very good level of French and English (spoken and written).
• Proven ability to conduct root cause analysis and implement risk-based decisions.

Nice to have

• Lean / Six Sigma knowledge or Green Belt certification.

Culture & Benefits

• Rapid career growth opportunities within a fast-expanding Belgian office.
• Opportunity to work on prestigious projects for renowned pharmaceutical and biotechnology clients.
• International, agile, and dynamic work environment promoting intrapreneurship.
• Inclusive workplace committed to diversity and equal opportunity.

Hiring process

• Brief virtual or phone discovery call.
• Average of 3 interviews with line managers and future colleagues.
• Potential case study or technical assessment depending on the position.