Validation Engineer

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.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

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

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.