Tyler TX
United States of America
Injection Molding
Date Posted

Validation Engineer

We have a great client in the Tyler, Texas area in need of a Validation Engineer. The ideal candidate will have experience in the following;

  • Validate and implement medical device manufacturing processes as assigned.
  • Support and provide validation oversight for capital expansion projects/build outs including packaging equipment and semi-automated and automated inspection systems
  • Author validation documentation and protocols (IOQ, PQ, CCOQ, component assessments) as well as document template, validation strategies, policies, master batch records, component assessments, validation project plans, engineering protocols (commissioning, FAT, SAT).
  • Conduct validation qualifications in accordance with all applicable protocols and identify associated exceptions.
  • Review facility changes and provide input on re-validation and re-qualification of equipment
  • Assess risks using FMEA or other risk analysis tools involved in processing steps related to equipment, developing and/or reviewing validation requirements and design deliverables.
  • Develops statistically sound sampling plans and incorporates statistical analysis on results to reach data driven conclusions.
  • Be a part of a cross functional team and work closely with other supporting groups including Global Engineering, Manufacturing Technology, Quality, and Operations to support and monitor validation and process improvement efforts
  • Identify equipment/fixture installation qualification requirements and characterization of processes and their outputs/acceptance criteria.
  • Written preparation of applicable validation reports that meet regulatory/company standards.
  • Orchestrates validation activities. Develops protocols for testing equipment. Executes test plans, and documents results in validation reports
  • Documenting and Managing Change - Justifies changes, quality and regulatory information, and manufacturing readiness information. Executes changes through document control and the quality system to implement project outcomes.
  • Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and Company's Quality Management System where applicable.
  • Must strictly adhere to safety requirements.
  • Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.

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