Validation Engineer

This individual assures validation activities are performed in conformance with applicable Standard Operating Procedures (SOPs), client standards, industry best practices, and regulatory requirements. The individual performs validation program-related activities such as DQ, COM, IQ, OQ, PQ, CQ, RQ, etc.

Essential Duties and Responsibilities:

• Writes and executes commissioning, qualification, & validation protocols for facilities utilities, equipment, and computerized systems

• Writes final reports

• Resolves protocol discrepancies and deviations

• Reviews vendor-generated validation protocol packages

• Supports change control deliverables

• Responsible for the generation of complex protocols using a risk-based approach that meets current regulatory requirements and industry practices

Requirements:

• Minimum of 0-1 year of experience.

• BS/MS in Mechanical/Industrial/Manufacturing/Biology/Chemical/Biochemistry/Biomedical Engineering.