What are the responsibilities and job description for the Sterilization Validation Lead position at Midwest Sterilization Corp.?
Key Responsibilities
The Validations Manager will be responsible for leading and mentoring the Validation Technical Support Team, ensuring compliance with company and industry standards.
This includes reviewing and approving sterility assurance validation protocols, including Process Performance Qualification (PQ), Microbiological Performance Qualification (MPQ), Routine cycle requalifications.
The manager will also oversee validation processing for medical device manufacturers, including process cycle development, equipment setup, and direct collaboration with customers.
In addition, the manager will conduct quality trend analysis and validation performance reporting at least annually.
- Bachelor's degree (STEM-related field preferred).
- 3 years of experience in validation, quality assurance, engineering, or a related field.
- Expertise in ISO 11135 (EO Sterilization of Healthcare Products), ISO 13485 (International Quality Systems), and CFR 820 (FDA Quality System Regulations).
