Contract position: Global leader in the medical product manufacturing industry is currently looking for a Sterilization Validation Engineer in Rocky Mount NC. 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. This is a contract position expected to last 12 months, possible extension. Currently we are only looking for local candidates. Great Contractor Benefits! Apply Now! Responsibilities for the Validation Engineer
Requirements for the 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.
- Bachelor Degree in Engineering
- 2+ years of relevant validation experience in a regulated industry preferably pharmaceutical or medical products
- 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 highly desired
- Must have a strong background working in cGMP environments
- Paid Vacation
- Health Insurance, and more...
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.