Aseptic Training Specialist

Aseptic Training Specialist I | Pharmaceutical Manufacturing | Geleen, Netherlands

Job Description

A global life sciences organisation is seeking an Aseptic Training Specialist I to ensure employees working in aseptic manufacturing environments have the knowledge, skills, and behaviours required to maintain high standards of aseptic practice. This site-based position focuses on hands-on training, coaching, aseptic behaviour monitoring, and continuous improvement of training standards and procedures.
In this role, you will deliver and coordinate GMP and aseptic training, coach employees and contractors in classified manufacturing areas, monitor gowning and aseptic practices, and support Manufacturing and Quality Assurance teams with training and compliance activities. You will also contribute to deviation investigations, CAPAs, risk assessments, audits, smoke studies, cleanroom management, and procedural improvements related to aseptic manufacturing.

Essential Requirements

· BSc or equivalent educational background in science or a related discipline
· Experience in a pharmaceutical, GMP, or similarly regulated manufacturing environment
· Experience delivering GMP training
· Knowledge of aseptic behaviour, sterile manufacturing practices, and relevant pharmaceutical regulatory requirements
· Experience with electronic GxP training platforms
· Ability to develop and deliver effective training materials
· Strong communication and coordination skills
· Ability to work effectively with employees, contractors, Manufacturing, and Quality Assurance stakeholders
· Self-starting and adaptable approach with strong attention to detail
· Ability to manage changing priorities
· Ability to analyse trends, identify improvement opportunities, and translate findings into practical actions

Preferred Requirements

· Experience providing hands-on coaching to employees and contractors entering aseptic and classified manufacturing areas
· Experience supporting aseptic behaviour certification programmes
· Experience monitoring aseptic practices, gowning techniques, and manufacturing activities
· Experience supporting smoke studies and cleanroom management
· Experience supporting the training and monitoring of personnel involved in cleaning activities
· Experience generating reports and trend analyses
· Experience supporting deviation investigations, CAPAs, risk assessments, and audits related to microbial contamination, aseptic procedures, and continuous improvement
· Experience evaluating equipment modifications, process changes, and new equipment or tools from an aseptic perspective
· Experience supporting procedural revisions and assessments

Practicalities
Location: Geleen, Netherlands
Contract Type: Permanent
Working Model: Fully site-based
Salary: €48,750-€68,250 annual base salary

Interested? Send your CV to Miguel Gomes at via de button "Solliciteer nu" op deze pagina. or call / +41 (0)44 5514 407 to discuss the opportunity.