Strong process understanding of moist heat, porous load sterilization and proficiency in use of the Kaye Validator
Autoclave thermal mapping experience essential
Knowledge of aseptic processing
cGMP regulations and latest validation guidelines
Able to work extended/odd hours around manufacturing schedule required
Responsibilities
Autoclave load configuration design, cycle development and performance qualification
Develop sound scientific rationale/strategy for validation of new or modified cGMP equipment and processes
Ensure all aspects of Sterilization Validation adhere to required policies and procedures, including safety and training
Writing and execution/coordination of sterilization protocol testing
Coordinate testing of qualification activities
Job Description
Qualifications
Sterilization Tech needs BS degree in a technical discipline
Sterilization Tech requires;
2 years relevant experience
Strong process understanding of moist heat, porous load sterilization and proficiency in use of the Kaye Validator. Autoclave thermal mapping experience is essential.
Knowledge of aseptic processing
cGMP regulations and latest validation guidelines.
Able to work extended/odd hours around manufacturing schedule required.
Sterilization Tech duties:
Autoclave load configuration design, cycle development and performance qualification.
Develop sound scientific rationale/strategy for validation of new or modified cGMP equipment and processes.
Ensure all aspects of Sterilization Validation adhere to required policies and procedures, including safety and training.
Writing and execution/coordination of sterilization protocol testing.5. Coordinate testing of qualification activities.