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Validation Engineer

2 months ago

Somerset, United States System One Holdings, LLC Full time
Title: Validation Engineer
Hours: Mon- Fri 8:30-5:00pm
Location: Somerset, NJ
Type: Direct Hire

Requirements:

  • Bachelor's degree in Engineering, Chemistry, or a related field.
  • Minimum of 3-5 years of experience in validation within a manufacturing environment, preferably in dietary supplements or pharmaceuticals.
  • Strong understanding of regulatory requirements and validation processes.
  • Proficiency in statistical analysis software and data interpretation.
  • Excellent problem-solving and communication skills.
  • Experience with computer system validation and knowledge of GAMP 5.
  • Familiarity with process validation in a highly regulated industry.
Responsibilities:
  • Develop and implement validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and processes.
  • Conduct risk assessments to prioritize validation activities across manufacturing sites.
  • Ensure compliance with industry regulations and standards, including FDA requirements for dietary supplements and OTC products.
  • Collaborate with cross-functional teams, including Quality Assurance, Production, and Engineering, to support validation activities.
    • Maintain and update the Validation Master Plan (VMP) and ensure all validation documentation is accurate and complete.
    • Troubleshoot and resolve validation-related issues and non-conformances.
    • Support continuous improvement initiatives by analyzing process data and implementing corrective actions.