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Senior Validation Engineer (Life Sciences)

108 200 - 162 200$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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TL;DR

Senior Validation Engineer (Life Sciences): Overseeing technical compliance and ensuring the integrity of manufacturing equipment and processes with an accent on IQ/OQ/PQ protocols and GxP regulatory standards. Focus on leading complex deviation investigations, managing change control, and maintaining inspection readiness.

Location: Onsite in Rensselaer, NY, USA

Salary: $108,200 – $162,200

Company

hirify.global is a professional staffing agency specializing in technical and scientific placements.

What you will do

  • Lead the review and approval of Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols and generate final reports.
  • Evaluate and approve Change Requests to ensure equipment and systems remain in a validated state.
  • Audit SOPs and technical documents to ensure continuous adherence to regulatory standards.
  • Conduct root cause analysis and lead deviation investigations for validation failures.
  • Represent the validation department during internal and external regulatory inspections.
  • Manage the Annual Product Review (APR) process through cross-functional coordination.

Requirements

  • Bachelor’s degree in Chemistry, Engineering, or a related technical field with 8+ years of experience (or Master's + 6 years / PhD + 4 years).
  • Must be based in or able to work onsite in Rensselaer, NY.
  • Expertise in root cause analysis and professional technical writing.
  • Strong understanding of regulatory requirements within a GxP environment.
  • Commitment to workplace safety and rigorous technical standards.

Culture & Benefits

  • Major medical, dental, and vision insurance for assignments lasting 13+ weeks.
  • 401k retirement plan.
  • Statutory sick pay where required.
  • Equal Opportunity Employer committed to reasonable accommodations for disabilities.

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