Description for Validation Engineer:
The Validation Engineer is responsible for coordinating and verifying quality standards in accordance with the requirements of the organization.
Responsibilities for Validation Engineer:
- Responsible for the validation of all required manufacturing equipment and processes in compliance with applicable internal and external requirements.
- Conducts IQOQPQ equipment validation
- Coordinates manufacturing process validation requirements and documentation with internal and external stakeholders.
- Supports the update and maintenance of validated processes
- Supports validation training.
- Builds, organizes, and maintains databases and/or logs of actions completed, pending actions, and current status
- Provides reports and data on assigned metrics.
- Creates and updates applicable procedures, work-instructions, forms, and other documentation as needed.
- Participates and supports ECO, CAPA, MRB and other Quality System processes
- Provides documentation and support during audits.
- Complies with all applicable regulatory requirements for medical devices such as FDA Quality System Regulation, 21 CFR 820, GMP guidelines, GDP, ISO 13485, ISO 14971 and other regulatory requirements.
- Manages multiple, often concurrent projects and meets deadlines.
- Coordinates acquisition of cross-functional resources.
Requirements for Validation Engineer:
- B.S. Degree in applicable technical discipline, such as mechanical, bio-medical or chemical engineering, required
- At least 2 years of professional experience conducting equipment validation utilizing IQOQPQ protocols in a manufacturing setting
- Experience with Design of Experiments (DOE)
- Applied understanding of statistical methods and tools, such as SPC, Six Sigma & Mini Tab required.
- Knowledge of ISO 13485 medical device quality standards
- Excellent communication skills, both written and verbal
- Advanced Excel skills
- Ability to work effectively in a small team environment and independently
- Experience with and understanding of cross-cultural differences and the ability to work within this environment is crucial for successful employment
Desired skills for Validation Engineer:
- Relevant experience or certifications demonstrating applied understanding of medical device quality system requirements, such as AAMI Quality System or sterilization certificates, Certified ASQ or ISO Lead Auditor and Regulatory Affairs Professional Society (RAPS) preferred
*Legal authorization to work in the U.S. is required. Will not sponsor individuals for employment visas, now or in the future, for this job opening