Key Skills

Job Description

We are currently looking for an experienced Gamma Sterilization Specialist to prepare and deliver a one-day training session for employees of one of our clients. Location: Gelderland, Netherlands Duration: 1 day Format: On-site training Preparation: The specialist will be expected to develop and prepare the training content in advance, based on the topics below, and deliver the session to the client’s employees. Required Expertise The specialist should have strong practical and technical knowledge of gamma sterilization, as well as a good understanding of the relevant regulatory and validation requirements. The training should cover the following areas: Sterilization Techniques General sterilization principles Gamma sterilization, e-beam, and X-ray Microbiology Microorganisms Endospores Material Impact and Aging Impact of irradiation on materials Material aging Dosimetry Sterilization and Batch Release Requirements MDR requirements ISO 11137-1, ISO 11137-2, and ISO 11137-3 ISO 13004 Product Families Determination and grouping of product families Equipment Qualification Qualification of sterilization equipment Process Validation Process validation principles Bioburden testing Sterility testing Periodic Dose Audits (PDA) What We Are Looking For The ideal specialist will have: Solid hands-on experience and subject-matter expertise in gamma sterilization A strong understanding of ISO 11137 and related sterilization standards Experience with sterilization validation, dosimetry, bioburden, and sterility testing Knowledge of MDR requirements and batch release The ability to translate technical and regulatory knowledge into a clear, practical training session Previous experience developing and delivering technical training is highly desirable Availability to deliver the training on-site Gelderland, Netherlands The specialist will be responsible for both preparing the training materials/content and delivering the one-day training session to the client’s employees.

Core Responsibilities

The specialist is responsible for developing comprehensive training content based on gamma sterilization principles and regulatory requirements. They will deliver a one-day on-site training session to the client's employees in Gelderland.

Requirements

The ideal candidate must possess strong technical expertise in gamma sterilization, ISO 11137 standards, and sterilization validation processes. Previous experience in developing and delivering technical training is highly desirable.