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.