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Senior Aseptic Cleanroom Training & Excellence Specialist

Lonza

Geleen
Full-time
5-10 years experience
On-site

€60,750 - €85,050 per year

Key Skills

Aseptic processing
Contamination control
GMP training
Coaching
Mentoring
Aseptic behavior certification
Gemba walks
Gowning
Aseptic techniques
Line clearance
Aseptic Process Simulation
Media fills
Smoke studies
Microbial contamination investigation
CAPA
Human factors

Job Description

 

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 at Lonza.


This 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.


What you will get:

  • 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: https://www.lonza.com/careers/benefits.

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.


What you will do:

  • 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.

What we are looking for:

  • 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 supporting Aseptic Process Simulations/media fills, smoke studies, garment monitoring, microbial contamination investigations or CAPAs would be an advantage.
  • A relevant scientific, technical, pharmaceutical or life sciences qualification is beneficial; equivalent practical experience in sterile manufacturing, aseptic training and contamination control will also be considered.

About Lonza


At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.


Ready to shape the future of life sciences? Apply now.

Core Responsibilities

The specialist will administer and improve the aseptic behavior certification program while conducting hands-on training and observations in manufacturing areas. They will also partner with quality teams to support investigations into microbial contamination and develop targeted action plans for employees.

Requirements

Candidates must have significant experience in a sterile or aseptic manufacturing environment with a strong understanding of cGMP and contamination control. Proven experience in delivering training or coaching programs within a regulated life sciences environment is required.

Benefits

  • Relocation assistance
  • Compensation programs
  • Professional development opportunities

About Lonza

Industry: Pharmaceutical Manufacturing

Company size: 10,001+ employees

Lonza is a pioneer and world leader in the CDMO industry, setting the pace with cutting-edge science, smart technology, and lean manufacturing. United by a common purpose, we turn our customers’ breakthrough innovations into viable therapies and manufacture the medicines of tomorrow. Founded in Switzerland in 1897, our company is the first and original CDMO, and today we are more dynamic, agile and forward-focused than ever before. As one of the largest Western CDMOs, we bring together a global team of around 18,500 colleagues across five continents to deliver comprehensive, integrated solutions for our customers' complex needs. For our customers and their patients, we bring quality, safety and reliability to bring life-enhancing and life-saving treatments to market at speed and at scale. For our colleagues, we strive to create a sense of belonging and inclusion where every person can thrive and bring their best.

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