Job Summary:

The Validation Engineer will oversee, evaluate, and calibrate equipment, systems, and procedures used in the development and production of products and will ensure safety, quality, and purity requirements are met.

Supervisory Responsibilities:

• None.

Duties/Responsibilities:

• Consults with management, assesses customer requirements, and studies product characteristics to select validation objectives and standards.
• Prepares protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems.
• Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.
• Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing.
• Identifies root causes of production problems.
• Identifies nonconformities of product or process standard and offers recommendations for resolving deviations.
• Develops and maintains databases for tracking test results, validation activities, or validated systems.
• Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notices.
• Modifies testing methods or revisits test objectives and standards to resolve testing problems.
• Calibrates equipment to ensure accurate measurements.
• Performs other related duties as assigned.

Required Skills/Abilities:

• Excellent verbal and written communication skills.
• Excellent interpersonal skills.
• Thorough understanding of industry standards and regulatory guidelines.
• Thorough understanding of applicable mathematics and scientific practices.
• Thorough understanding of related equipment and the ability to perform equipment modifications.
• Proficient with Microsoft Office Suite or related software.

Education and Experience:

• Bachelors degree in related field required.
• At least one year of related experience preferred.

Physical Requirements:

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.
• Must be able to manipulate equipment for calibration and modification.