Senior Aseptic Cleanroom Training & Excellence Specialist

Location:

Geleen, Netherlands The actual location of this job is in Geleen, The Netherlands. Relocation assistance is available for eligible candidates and their families, if needed.

Join our team in Geleen and play a key role in maintaining the highest standards of aseptic behavior and contamination control within a sterile manufacturing environment. As a Senior Aseptic Cleanroom Training & Excellence Specialist, you will provide hands-on training, coaching and mentoring to employees across manufacturing and support functions, helping to strengthen aseptic practices and contribute to the quality and safety of medicines manufactured s is a fully site-based role.

Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Opportunities to develop specialist expertise in aseptic manufacturing, contamination control and GMP training.
• A variety of benefits dependent on role and location. The full list of our global benefits can be found here:
• The full-time annual base pay for this position in The Netherlands is expected to range between EUR 60.750,- and EUR 85.050,-. Initial salary placement within this range will be determined based on role-related factors such as experience, qualifications, and expected contribution.

• Administer and continuously improve the aseptic behavior certification program for employees working in the sterile manufacturing environment, including manufacturing, cleaning and facilities teams.
• Conduct regular Gemba walks and hands-on observations in classified manufacturing areas to reinforce correct gowning, aseptic techniques and behaviors.
• Act as a hands-on trainer and coach for aseptic behavior, providing practical guidance on contamination control and maintaining low bioburden during line clearance, cleaning, manufacturing runs and routine or non-routine interventions.
• Monitor Aseptic Process Simulation (APS) media fills, commercial manufacturing activities and smoke studies, identifying opportunities to improve training methodologies, aseptic practices and training materials.
• Develop and deliver GMP training modules focused on aseptic behavior, contamination control and maintaining a compliant classified manufacturing environment.
• Partner with Manufacturing and Quality teams to develop targeted action plans for employees requiring additional support with aseptic technique, including where garment monitoring identifies opportunities for improvement.
• Support investigations into microbial contamination and related corrective and preventive actions (CAPAs), with a focus on human factors, employee behaviors and opportunities to strengthen the aseptic manufacturing environment.

• Proven experience delivering training, coaching or qualification programs within a GMP-regulated pharmaceutical, biotechnology or other life sciences environment.
• Significant experience working in a sterile or aseptic manufacturing environment, with a strong understanding of contamination control and aseptic techniques.
• Strong working knowledge of current Good Manufacturing Practices (cGMP), aseptic processing principles and contamination control expectations for classified manufacturing environments.
• Demonstrated ability to work hands-on in manufacturing areas and confidently engage, coach and mentor employees across different functions and levels.
• Strong observation, communication and interpersonal skills, with the ability to provide.
• Experience…