Associate Validation Engineer Job at Openkyber, New York, NY

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  • Openkyber
  • New York, NY

Job Description

Role :- Validation Lead with Oracle Process Manufacturing (OPM):

Location :- Chicago, IL-Onsite:

Duration :- 12+ Months:

Role Overview:
  • We are seeking a skilled Validation Testing Specialist with deep expertise in Oracle Process Manufacturing (OPM) to support validation efforts across manufacturing systems.
  • The ideal candidate will ensure compliance with regulatory standards and deliver high-quality validation documentation and testing outcomes.
Key Responsibilities:
  • Lead validation testing activities for Oracle Process Manufacturing modules including recipe management, batch processing, and quality control.
  • Develop and execute validation protocols (IQ/OQ/PQ) aligned with CSV and CSA methodologies.
  • Ensure compliance with ICH Q9 Guidelines and other relevant regulatory frameworks.
  • Collaborate with cross-functional teams to define test strategies and acceptance criteria.
  • Perform integration testing with systems such as MES , ESB , and other enterprise platforms.
  • Document test results, deviations, and corrective actions in accordance with SOPs.
  • Support audit readiness and respond to inspection queries related to validation deliverables.

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