Process Validation Specialist

Location: Fort Wayne, IN

Position: Process Validation Specialist

Location: Fort Wayne, IN

Compensation: Base Salary $80,000-$90,000 plus annual bonus

Plus, a $5,000 Sign-On Bonus

Benefits: Comprehensive Insurance and Retirement Package

Relocation assistance is not available for this position


Position Summary: As a Process Validation Specialist, you will be responsible for supporting process development, engineering, and validations. This includes leading and executing projects for process and equipment improvements. You will also communicate with customers to understand their requirements and develop custom processes and validations to meet those needs.

Position Requirements

  • Bachelor’s Degree in Engineering
  • Minimum of 5 years of engineering and project management experience
  • Excellent oral and written communication skills
  • Knowledge of Root Cause Analysis, SPC Analysis, and process and design FMEA's
  • Six Sigma Black Belt or Green Belt certification

Position Responsibilities:

· Act as the primary process engineer for operations, troubleshooting issues, and improving reliability, quality, and cost in various operations

· Lead the development and execution of capital projects, including forming project teams and ensuring successful startup

· Identify and deliver continuous improvements related to safety, quality, reliability, etc.

· Lead MOC process and document all changes

· Design, lead, and perform validation work for processing equipment and methods, using the IQ/OQ/PQ methodology

· Oversee the installation of new equipment, ensuring safe practices and documenting all changes

· Lead and assist in the elimination of quality issues using analytical tools

· Interface with customers on process validation and qualification efforts

· Continuously improve knowledge of validation methods and techniques and train employees on validations

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