Sterility Assurance Manager

Nalys; Henegouwen; On-site; EUR 90,000 - 140,000; Full time

Job summary

Nalys is a growing consultancy company specialized in high-tech engineering and life sciences. As Sterility Assurance Manager, you will join the Quality organization of a sterile pharmaceutical manufacturing site operated by a leading global life sciences company, acting as the reference expert for aseptic processing and contamination control.

You will shape the site's contamination control approach, drive continuous improvement of aseptic practices, and lead audits and inspections with a

Qualifications

• Master's degree in microbiology, pharmacy, bioengineering or a related scientific field.
• Extensive experience in sterility assurance and aseptic manufacturing within GMP.
• Deep knowledge of EU GMP Annex 1 and contamination control.
• Experience with environmental monitoring programs and simulations.

Responsibilities

• Own and maintain the site Contamination Control Strategy and related sterility documentation
• Lead the Aseptic Improvement Plan with site departments
• Approve aseptic process simulation strategies
• Write environmental monitoring qualification protocols and reports for classified areas
• Define risk-based EM sampling locations and frequencies
• Conduct on-the-floor audits and share findings
• Ensure sterilization and filtration processes meet requirements
• Participate in major investigations with potential impact on sterility
• Approve periodic EM reports and execute interventions in classified areas
• Escalate critical events to Quality leadership with an action plan
• Present sterility assurance topics during client audits and regulatory inspections
• Train staff on gowning, cleaning, material transfer, EM sampling, aseptic practices
• Share best practices within a global network of sterility assurance experts

Skills

Sterility assurance

Aseptic manufacturing

QA/QC microbiology

GMP knowledge

EU GMP Annex 1

Environmental monitoring

Investigations leadership

Training and coaching

Stakeholder communication

On-site leadership

Education

Master's degree in microbiology/pharmacy/bioengineering or related field

Job description

Nalys is a growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains.

At Nalys, we believe in combining deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed.

Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.

Job Description

As a Sterility Assurance Manager, you will join the Quality organization of a sterile pharmaceutical manufacturing site operated by a leading global life sciences company.

You will be the site's reference expert for aseptic processing and contamination control, making sure that every product leaving the site meets the highest sterility standards.

This role combines strategy, hands-on presence in classified areas, and expert guidance.

You will shape the site's contamination control approach, drive continuous improvement of aseptic practices, and act as the voice of sterility assurance during audits and inspections.

We're looking for someone with deep technical expertise, strong field credibility, and the ability to build a lasting sterility assurance culture across teams.

The Role & Responsibilities

Working closely with the Site Quality Head, Operations, QC, and technical support teams, your responsibilities will include:

• Owning and maintaining the site Contamination Control Strategy and related sterility documentation
• Leading the Aseptic Improvement Plan in partnership with the other site departments
• Approving aseptic process simulation strategies
• Writing environmental monitoring qualification protocols and reports for classified areas
• Defining risk-based EM sampling locations and frequencies for production areas and utilities
• Conducting regular on-the-floor audits and sharing findings with production and support teams
• Ensuring sterilization and filtration processes are performed in line with requirements
• Taking part in major investigations with a potential impact on product sterility
• Approving periodic EM reports and final execution of technical interventions in classified areas
• Escalating critical events to Quality leadership together with a proposed action plan
• Presenting sterility assurance topics during client audits and regulatory inspections
• Training staff on gowning, cleaning, material transfer, EM sampling, and aseptic practices
• Sharing best practices within a global network of sterility assurance experts.

Skills & Qualifications

• You hold a master's degree in microbiology, pharmacy, bioengineering, or a related scientific field
• You have significant experience in sterility assurance, aseptic manufacturing, or QA/QC microbiology within a GMP sterile environment
• You have in-depth knowledge of EU GMP Annex 1 and contamination control principles
• You are experienced with environmental monitoring programs and aseptic process simulations
• You are comfortable leading investigations and defending your approach during regulatory inspections
• You are a recognized trainer and coach, credible both on the floor and in the meeting room
• Your communication is clear and effective with stakeholders at every level
• You have a strong sense of ownership and thrive in a demanding, quality-driven environment.

The Recruitment Process

By applying for the "Sterility Assurance Manager" position, you will go through the following steps in our recruitment process:

• Olivia Braszko, TA Specialist, will analyze your resume and cover letter and schedule a first screening to assess your motivation and answer your questions
• You will have a second interview with one of our Technical Experts
• The last interview will be with our Business Unit Director, Jimmy Rousseaux.

Interested?