Validation Lead with Oracle Process Manufacturing -(Healthcare domain)

Overview

On Site
Depends on Experience
Accepts corp to corp applications
Contract - Independent
Contract - W2
Able to Provide Sponsorship

Skills

OQ
Health Care
IQ
Inspection
Integration Testing
Management
Manufacturing
Auditing

Job Details

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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