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Validation Specialist

2 months ago

New Brunswick, New Jersey, United States On Target Staffing Full time
Validation Engineer

We're seeking a skilled Validation Engineer to contribute to the success of our dynamic dietary supplement and OTC manufacturing company. As a key member of our team, you'll play a crucial role in validating our manufacturing systems and processes to ensure they meet quality, safety, and regulatory standards.

Key Responsibilities:

  • Develop and implement robust validation protocols, including IQ, OQ, and PQ, to guarantee the quality and safety of our manufacturing operations.
  • Conduct comprehensive risk assessments to identify and address potential validation risks.
  • Ensure compliance with industry regulations and standards, including FDA requirements for dietary supplements and OTC products.
  • Collaborate with cross-functional teams to support validation activities and drive continuous improvement in our manufacturing processes.
  • Maintain and update the Validation Master Plan (VMP) to ensure the accuracy and completeness of all validation documentation.
  • Troubleshoot and resolve validation-related issues and non-conformances promptly and effectively.
  • Drive continuous improvement by analyzing process data, identifying areas for improvement, and implementing corrective actions.

Requirements:

  • Bachelor's degree in Engineering, Chemistry, or a related field.
  • Minimum of 3-5 years of hands-on validation experience in a manufacturing environment, ideally within the dietary supplement or pharmaceutical industry.
  • Strong knowledge of regulatory requirements and validation methodologies.
  • Proficiency in statistical analysis software and data interpretation.
  • Excellent problem-solving and analytical skills.
  • Experience with computer system validation and a solid understanding of GAMP 5.
  • Familiarity with process validation in a highly regulated industry.