Validation Engineer

Job Description One of our large Medical Device companies is seeking a Validation Engineer to lead and support cross-functional validation and implementation activities to qualify raw materials, processes, equipment, and systems, ensuring timely execution and compliant documentation.

Their responsibilities will include:

• Plan and execute multiple validation and implementation projects across manufacturing platforms, from strategy through final report approval.
• Develop and qualify material, equipment, and process changes by authoring and executing protocols (IQ/OQ/PQ) and documenting results against acceptance criteria.
• Apply structured problem-solving (e.g., RCA/5-Why/FMEA) to investigate issues, define corrective actions, and prevent recurrence during validation and routine operations.
• Drive project management for qualification activities, including schedules, risk/issue tracking, stakeholder updates, and readiness for approval.
• Identify and implement improvements to manufacturing equipment, processes, and systems based on data analysis, investigations, and validation outcomes.
• Own validation documentation deliverables, including plans, protocols, executed test records, deviation investigations, final reports, and change control submissions per the quality system.
• Troubleshoot unplanned downtime or excessive rejects during protocol execution by coordinating containment, documenting deviations, and defining re-test or recovery plans to complete validations.
• Prepare technical justifications for capital and expense requests, including scope, risk, benefits, and implementation/validation approach We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.

We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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Skills and Requirements Education:

Bachelor's in engineering Primary focus areas:

Materials, Mechanical, Industrial, Chemical Engineering or Equivalent Years of Experience:

Minimum 2-5 years of significant engineering and/or operational experience is required. Experience in a regulated industry (medical device preferred) with familiarity with FDA expectations Experience with successfully performing

IQ/OQ/PQ

Qualifications and Change Request Management highly preferred Six Sigma certification (Green Belt/Black Belt) is a plus