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Lead Validation Engineer in Manufacturing
2 months ago
The Lead Validation Engineer in Manufacturing is responsible for the assessment and documentation of medical device production processes.
Key Responsibilities:
1. Validate and implement assigned medical device manufacturing processes.
2. Identify requirements for equipment and fixture installation qualifications.
3. Characterize processes along with their outputs and acceptance criteria.
4. Prepare comprehensive validation reports that comply with regulatory and company standards.
5. Conduct verification testing and manage projects effectively.
6. Maintain accurate and timely records and reports.
7. Exhibit strong analytical and problem-solving capabilities.
8. Demonstrate a positive attitude, strong work ethic, and self-motivation while managing multiple projects with minimal supervision.
Documentation and Compliance:
Ensure the preparation and maintenance of precise documentation in line with relevant regulations and Cook's Quality Management System.
Collaboration:
Work effectively and professionally with colleagues across various levels of the global organization, adhering strictly to safety protocols and maintaining regular attendance.
Qualifications:
- Bachelor's degree in Engineering or a related field.
- A minimum of 5 years of engineering experience in a regulated industry, ideally within medical manufacturing; 7 years preferred.
- Proven experience in analytical skills and problem-solving.
- Strong communication skills and experience working with diverse teams.
- Ability to work independently and guide others towards shared objectives.
- Proficiency in Microsoft Office Suite and relevant engineering software.
Physical Requirements:
Must be capable of performing essential job functions, subject to reasonable accommodations as per ADA guidelines.
Equal Opportunity:
Cook Incorporated is committed to being an equal employment opportunity employer for all individuals, including minorities, women, protected veterans, and individuals with disabilities.
