Validation Engineer

The Validation Engineer (IQ/OQ/PQ) will develop, write and execute validation protocols for a pharmaceutical and or food manufacturing equipment.  You will be responsible for the theory and content of validation documents and procedures for new equipment, systems, software, and any engineering changes in addition to interfacing with multiple departments including manufacturing, engineering, and project management.  Additional responsibilities will include tracking progress and maintaining project schedules.

 

YOUR ROLE WILL BE TO:

  • Demonstrate a sound knowledge, application and proper implementation of technical, quality and scientific principals necessary to meet industry and customer requirements
  • Develop, write, and execute validation protocols for automated PLC based manufacturing equipment.
  • Develop verification and qualification deliverables including requirements, documents, and summary reports.
  • Generate design specifications
  • Generate and execute IQ/OQ/PQ protocols including resolving any non-conformance/deviation issues
  • Generate deliverables that will satisfy customer requirements and stay within defined scope.
  • Track and manage change control activities

 

REQUIREMENTS:

  • At least 5 years of experience in the pharmaceutical, medical device or food manufacturing industries is required
  • Strong equipment based background which must include automated assembly, process, or material handling equipment
  • Proven experience in Equipment Validation/Software Validation, Controls systems software (HMIs, PLCs, etc.).
  • Must have experience working in a FDA/GMP regulated environment
  • Exposure to Allen Bradley, Siemens, or Rockwell software (HMI/PLCs) is required
  • Ability to interface with multiple companies and departments simultaneously
  • Reasonable keyboard and Microsoft office skills
  • Project Management experience