Sterility Assurance Manager
Life Sciences
Validation and Qualification
Senior (7+)
- Location
- Wavre, Walloon Brabant
- Work type
- Consultancy
- Work model
- Fulltime, Hybrid
Our client, a leading pharmaceutical organization, is seeking a Sterility Assurance Manager. This role focuses on developing and overseeing the sterility assurance program to maintain safety and regulatory compliance in vaccine production. The position serves as a technical expert in microbiology and aseptic processes to drive continuous improvement across manufacturing units.
Responsibilities
- Develop and maintain a comprehensive sterility assurance roadmap, including ownership of the Contamination Control Strategy.
- Monitor manufacturing processes to identify contamination sources and implement necessary corrective and preventive actions.
- Interpret microbiological data and trends to provide holistic recommendations for process improvements.
- Perform facility design assessments and oversee risk assessments for environmental monitoring and aseptic processes.
- Drive compliance with GMP and QMS requirements through regular gap analyses and performance monitoring.
- Act as a technical expert during regulatory inspections, corporate audits, and internal reviews.
Requirements
- Bachelor’s or Master’s degree in Pharmacy, Biology, Biochemical Engineering, or a related scientific field.
- You bring 5+ years of professional experience in a pharmaceutical manufacturing environment focused on sterile drugs or vaccines.
- You have extensive knowledge of sterility assurance including Contamination Control Strategy, aseptic processes, environmental monitoring, and bioburden/endotoxin risk assessments.
- You possess strong expertise in quality and compliance such as cGMP, QMS, and root cause analysis.
- You're a proactive problem-solver with strong communication and influencing skills.
- You are fluent in French and English.
Nice to Haves
- Knowledge of Lean Six Sigma methodologies or Green Belt certification.
- Experience in training and mentoring staff on aseptic techniques.
Offer
- Enjoy a competitive salary package with extra perks that recognize your talent.
- Advance your career with a clear growth path, coaching, and mentoring to support you.
- Thrive in a dynamic and supportive environment where you can truly make an impact.
- Work when and where you perform best, ensuring an optimal work-life balance.
- Choose a flexible transport solution, from a company car to a public transport subscription.
- Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
- Grow your skills with external courses and our in-house Pauwels Academy.
- Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
- Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
Thank you for your interest. Unfortunately, job applications are not available in your region. To ensure a high-quality match for our clients and streamline the application process, we have certain regional limitations in place. We value all potential candidates and encourage you to explore opportunities with us in the future.
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