Process Validation Engineer
Location: Fort Wayne, IN
About the job: The Process/Validation Engineer serves as the primary process engineer and support all operations in process development, engineering, and validations. This involves initiating, leading, coordinating, and executing projects, process and equipment improvements, and validations. Communicating with customers on expectations, and creating custom processes and validations required to satisfy customer requirements.
Job Description:
- Primary process Engineer for operations, trouble-shooting issues and driving continual improvements in reliability, quality, and cost (compression molding, ram extrusion, annealing, blending & cross-linking operations)
- Lead the development and execution of new Capital Projects. Includes forming and leading project teams, informing stakeholders of progress and successful startup of all scope.
- Lead the identification and delivery of non-capital related continuous improvements necessary in the areas of Safety, Quality, Reliability, etc.
- Lead MOC process and all documentation.
- Design, Lead, and perform validation work for the area with respect to processing equipment and methods. Leading the use of the IQ / OQ / PQ methodology and ability to communicate with customers through their in-house change control systems.
- Oversee the installation of new equipment (physical installation, managing contractors, following all safe practices, documentation of all changes, etc.)
- Lead and assist in the elimination of quality issues on site with the use of tools including Root Cause Analysis, 5 Why, Process FMEA’s and SPC analysis tools.
- Serve as an interface with the customer on process validation and qualification efforts. Assist in the development of combined validation efforts, and describe and explain validation documentation to customers.
- Continually improve knowledge of validation methods and techniques; train employees on validations to improve the overall quality of validation knowledge and performance.
Job Requirements:
- Bachelor’s Degree in Engineering
- Minimum of 5 years of engineering and project management experience
- Good oral and written communication skills
- Root Cause Analysis, 5 Why, SPC Analysis, process, and design FMEA’S.
- 6 Sigma Black Belt or Green Belt
Salary: $80-$90,000 "range" + Signing Bonus
