Validation Engineer

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.