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Sterilization Validation Engineer

LanceSoft Inc.
Rocky Mount, North Carolina, United States
April 10, 2019


Job Description:

Sterilization Validation / Process Engineer- equipment

•The Sterilization Engineer will be responsible for ensuring that the sterilization validation activities associated with the porous load steam sterilizers supporting the Aseptic Manufacturing Facility are in compliance with Quality System requirements and recognized international standards. An emphasis will be placed on cycle development and performance qualification.

Sterilization validation Engineer


•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.

• Compile and report on relevant validation data and generate summary reports to document the results of the validation studies.

•Aides in troubleshooting/impact assessment for atypical conditions during sterilization runs/validations.

•Experience in root cause analysis.

•Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.

•This position will have interactions with Manufacturing, Quality, Engineering and Validation Personnel at both entry and senior level positions.

•The candidate would need good people skills and get along well with others in a team environment.

Sterilization Validation Engineer:

•Strong process understanding of moist heat, porous load sterilization and proficiency in use of the Kaye Validator. Autoclave thermal mapping experience is essential. Other commissioning experience is an advantage. Possess strong project management, organizational, analytical, computer, writing and communication skills. Knowledge of aseptic processing highly desired. Knowledge of cGMP regulations and latest validation guidelines. Able to handle multiple priorities in a fast-paced environment. Able to work extended/odd hours around manufacturing schedule required.

•Candidate must be able to Lift and carry light loads as necessary in conducting testing, sitting, standing, walking, weekend or long hours based on testing schedule, wear proper gowning and PPE in manufacturing areas as required to meeting GMP and OSHA requirements.

Education And Experience:

•BS degree in a technical discipline

•0-2 years relevant experience