Staff Validation Engineer

Position 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:
Bachelors 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