Required Skills:

-Bachelor’s degree in related field required

-multiple years of experience within the Medical Device or Pharmaceutical Industry supporting the manufacture of Regulated Products

-Expertise of validation in a FDA Regulated Environment.

-Knowledge and understanding of

• Quality standards (e.g., 21 CFR Part 820, ISO 13485)
• Quality tools (e.g. FMEA, Risk Analysis, Root Cause Analysis)
• Computer Systems (e.g. TrackWise, MasterControl, AGILE, SAP)

-Direct experience leading or supporting a project team responsible for validation

-Direct experience leading or supporting mixing and cleaning validations for formulation vessels and fill lines.

Day-to-Day:

Insight Global is looking for a Validation Engineers of all levels for a client in Middletown, VA. This person will oversee development and execution of project validation master plans and identify approaches based on risk. The Validation Engineer will also manage timelines, metrics, scope, and site reporting requirements, as needed. This position will demonstrate complete understanding of validation related activities to independently manage the strategy around increasingly complex projects.

Key Responsibilities:

• Independently manages validation project work, tracks overall project 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.

•Authors and executes qualifications and validations

• 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 associated with validation

• 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

• Identifies scale up and cost savings opportunities and directly plans and supports scale up, optimization, and development of new manufacturing processes