A Day in the Life
Performs process technician duties in Project Harmony NPI.
Responsibilities
* Working with the Advanced Manufacturing Engineering and supporting Operations teams to contribute to the development and qualification of robust processes for new products.
* Preparing & reviewing validation protocols, results from trials and test work, parameter development, operational qualifications, including challenge tests to establish and demonstrate stable processes and capability.
* Preparing & reviewing validation performance qualification protocols and reports, checking measurements, analyze data, compiling documentation.
* The role also involves helping to ensure our products are manufactured to comply with product design requirements and Quality compliance.
* Meeting with cross functional teams to progress projects, giving insight into qualification/validation requirements and making recommendations.
* Constructs, troubleshoots, calibrates, adjusts, tests, diagnoses, and maintains equipment, components, devices, or systems.
* Performs set up/alignment checks; makes adjustments, modifications, and replacements as directed; prepares prescribed compounds and solutions.
* Performs a variety of duties in the quality, engineering, process, and development areas.
* Can interpret schematics, engineering drawings, written verbal instructions.
* Understands the operation and functionality of process equipment; conducts tests and reports data in prescribed format.
* Verifies qualification measurements, data, checks as required, to ensure right first-time entries into protocols and reports.
Key Skills & Experience
* NFQ Level 6 or higher in a technical discipline.
* Requires minimum of 4 years of relevant experience in a highly regulated environment, typically Medtech/Pharma/Plastics processing environments.
* Experience in planning, preparing and executing validations protocols and reports, writing and implementing procedures, development of processing parameters, executing and documenting trials, IQ/OQ/PQ, navigating quality management systems.
* Experience in writing SOPs, Standard Work’s and Reports.
* Familiar with problem solving techniques and methodologies.
* Ability to adjust or recommend enhancements to systems, tooling and processes to solve problems or improve effectiveness of job area.
* Can work independently with general supervision.
* A good communicator and dynamic team player.
* Willingness to travel for equipment qualification testing and training.
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