Validation Engineer

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

Loves Park, United States IMA AUTOMATION Full time

IMA Automation North America designs and builds turn-key assembly solutions for the medical device automotive and other selected industries. Our engineered solutions support our customers’ assembly and test projects at every stage in the product development life cycle. From concept to prototyping, low to high volume production, we have the comprehensive experience and know-how to help achieve production goals. We currently have an opening for a Validation Engineer.


Validation Engineer

Under minimal direction and supervision, the Validation Engineer will provide the coordination, creation and execution of validation activities including (but not limited to) writing protocols, performing qualifications, review of documents that support the manufacturing of automated equipment. In addition, the candidate will have to have an understanding of how the various pieces of automated equipment operate and the principle of Validation.

Education, Experience and Skills

  • Bachelor’s degree with three to five years of directly related experience or equivalent combination of education and experience is required.
  • Strong communication and interpersonal skills and a demonstrated ability to work in a cross-functional team environment is essential.
  • Knowledge of cGMP / Gamp5 requirements and current industry practices.
  • Must have a strong knowledge of computer programs such as Windows, Excel, Word, Outlook and Project.
  • The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules.
  • Understanding of ISO9001 & ISO13485.


Duties and Responsibilities

  • Assist with the administration, creation and execution of Validation plans and validation protocols for projects.
  • Coordinates all validation activities by constant communication with affected departments and personnel.
  • Prepare and /or revise validation protocols/procedures as required.
  • Review and execute qualification and summary reports, write and revise as needed.
  • Participate in customer design reviews.
  • Work under the confines of the project schedule and budget.
  • Analyze validation data, prepare reports, and make recommendations for changes and or/improvements.
  • Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity.
  • Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity.
  • Interface with manufacturing, Mechanical and Controls Engineering group.
  • Have an understanding of PLCs and HMIs pertaining to validation activities.
  • Innovate and use good judgment to incorporate IMA standards and regulatory requirements.
  • Communicate ideas and comprehend information both verbally and in written form.
  • Follow all policy and procedures to maintain ISO9001 Certification requirements.
  • Prioritize, plan, and organize work and workspace.
  • Provide necessary documentation and support for machinery Operating Manuals.
  • Travel or extend workday - 20% travel is required.

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