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Validation Engineer

Intellectt INC

Hello,
I hope you're doing well.
My name is Purna , and I'm reaching out from Intellectt Inc . regarding an exciting opportunity for a Validation Engineer based in North Haven,CT (Onsite) with one of our prestigious clients. I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at View email address on us.fitly.work .

Title: Validation Engineer



Location : North Haven,CT



Job Description

  • 5+ years of experience in Validation / Quality Engineering
  • Strong experience with IQ/OQ/PQ and Process/Equipment Validation
  • NCR and CAPA experience is mandatory
  • Hands-on experience with Root Cause Analysis (RCA)
  • Experience in Medical Device / Pharmaceutical / regulated industry
  • Knowledge of FDA regulations, ISO 13485, and ISO 14971
  • Strong documentation and technical writing skills

Key Responsibilities

  • Develop and execute validation protocols and reports.
  • Support equipment, process, and manufacturing validations.
  • Investigate and resolve NCRs and support CAPA activities.
  • Perform root cause investigations and implement corrective actions.
  • Support deviations, change controls, risk assessments, and validation documentation.
  • Work closely with Quality, Manufacturing, and Engineering teams.


Thanks & Regards,
Purnasree.U

Recruiter
Intellectt Inc


View email address on us.fitly.work
Desk number: View phone number on us.fitly.work

Vacancy posted 1 day ago
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