Our client is a leading international biopharmaceutical manufacturing organization focused on the production of sterile medicines and advanced therapeutic products. To support ongoing growth and operational excellence, they are looking for an
Aseptic Training Specialist
to strengthen their manufacturing training team.
In this role, you will play a key part in developing and maintaining aseptic training standards, coaching personnel in cleanroom environments, and ensuring compliance with GMP and sterile manufacturing requirements.
Training Specialist Limburg | Full-time
Responsibilities
Deliver onboarding and GMP training focused on aseptic behavior and cleanroom best practices.
Coach operators, technicians, and contractors working in classified manufacturing environments.
Support aseptic qualification and certification programs for cleanroom personnel.
Observe manufacturing activities, gowning practices, and aseptic behaviors to identify training opportunities and compliance risks.
Develop, update, and improve training materials, SOPs, and qualification programs.
Analyze trends and training data to drive continuous improvement initiatives.
Support cleanroom monitoring activities, smoke studies, and cleaning-related training programs.
Collaborate with Manufacturing, Quality Assurance, and Operational Excellence teams.
Contribute to deviation investigations, CAPAs, risk assessments, and inspection readiness activities.
Review equipment and process changes from an aseptic compliance perspective.
Requirements Knock-out criteria
Experience working within a pharmaceutical GMP manufacturing environment.
Experience with aseptic processing, sterile manufacturing, or cleanroom operations.
Experience delivering GMP, compliance, or operational training.
Additional Requirements
Bachelor's degree in Biotechnology, Life Sciences, Pharmaceutical Sciences, Microbiology, or a related field.
Good understanding of GMP regulations and aseptic manufacturing principles.
Experience working in regulated pharmaceutical or biotechnology environments.
Familiarity with electronic learning management systems (LMS) and GxP training platforms.
Strong communication and coaching skills.
Ability to influence behaviors and support a culture of operational excellence.
Strong analytical mindset with the ability to interpret trends and implement improvements.
Fluent English communication skills.
Desired Skills and Experience
Good Manufacturing Practice (GMP)
Aseptic Processing
Sterile Manufacturing
Cleanroom Operations
Training & Coaching
CAPA
Quality Assurance
Root Cause Analysis
Pharmaceutical Manufacturing
Microbial Contamination Control
#J-18808-Ljbffr
GMP Cleanroom trainer in Maastricht werkgever: Progressive
Bij onze innovatieve organisatie in de omgeving van Rotterdam krijg je als Security Engineer de kans om je passie voor security te combineren met een dynamische werkomgeving. We bieden een informele cultuur waarin persoonlijke groei en ontwikkeling centraal staan, ondersteund door opleidingen en coaching. Met een focus op digitalisering en teamactiviteiten zorgen we ervoor dat je niet alleen professioneel, maar ook persoonlijk kunt bloeien.
