What are the responsibilities and job description for the Validation Manager position at CEDENT?
Key Responsibilities:
- Lead and mentor the Validation Technical Support Team, ensuring compliance with company and industry standards.
- Review and approve sterility assurance validation protocols, including: Process Performance Qualification (PQ), Microbiological Performance Qualification (MPQ), Routine cycle requalifications
- Oversee validation processing for medical device manufacturers, including process cycle development, equipment setup, and direct collaboration with customers.
- Assign and manage validation activities within the team, ensuring timely and efficient execution.
- 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).
- Strong problem-solving and leadership skills with a detail-oriented mindset.
