What are the responsibilities and job description for the Validation Engineer position at Katalyst Healthcares & Life Sciences?
We are looking for an experienced Validation Engineer with a strong background in the Medical Device industry to support validation and project execution activities.
Key Requirements:
Key Requirements:
- bachelor's degree in mechanical engineering
- Prior experience in the Medical Device domain (Mandatory)
- Strong knowledge of ISO 13485 and ISO 14971
- Experience with IQ, OQ, and PQ validation activities
- Validation planning, execution, and documentation
- Equipment, process, and product transfer validation experience
- Cross-functional collaboration and stakeholder management
- Experience coordinating with customers, manufacturing plants, and offshore teams
- Project Management / Project Lead experience is a plus
Responsibilities:
- Plan, lead, and coordinate validation activities
- Support validation execution for equipment, process, and product transfers
- Author and review validation protocols and reports
- Ensure compliance with regulatory and quality standards
- Drive project continuity and on-time delivery.