Staff Validation Engineer

Job Summary:

• The Staff Validation Engineer will oversee development and execution of validation master plans and identify approaches based on risk.
• The Validation Engineer will also oversee other Validation Engineers and consultants as well as develop, scale up, optimize, evaluate, and calibrate equipment, systems, and write procedures and protocols.
• The Validation Engineer will also manage timelines, metrics, Product, and site reporting requirements.
• This position will demonstrate complete understanding of validation related activities to independently manage the strategy around increasingly complex projects.

Key Responsibilities:

• Independently manages other validation engineers and/or consultants, tracks overall validation master plan progress and provides dashboard updates to senior management.
• Consults with management, assesses customer requirements, and studies product characteristics to select validation objectives and standards.
• Develops validation strategies and approaches consistent with all applicable site guidance documents and writes protocols for validation or performance testing of manufacturing equipment, processes, or systems.
• Applies current validation best practices and knowledge of risk-based validation approaches across a wide range of manufacturing sub-assembly and assembly processes.
• Executes qualifications and validations as needed.
• 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.
• Identifies scale up and cost savings opportunities and directly plans and supports scale up, optimization, and development of new manufacturing processes.

Minimum Requirements/Qualifications:

• Bachelor’s degree in related field required.
• 11-15 years of experience in biotech manufacturing, quality, engineering, or validation required.

Personal Attributes:

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