Validation Engineer

Requirements

• Design and develop validation protocols for SCADA technology used in the manufacture of cell and gene therapy products.
• Execute validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV).
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs, to ensure alignment of validation activities with regulatory requirements and company standards.
• Perform risk assessments and impact analyses to identify potential validation gaps and develop mitigation strategies.
• Generate and maintain validation documentation, including protocols, reports, and standard operating procedures (SOPs), in compliance with regulatory guidelines and internal procedures.
• Conduct validation testing and data analysis to ensure the reliability, repeatability, and robustness of manufacturing processes and systems.
• Investigate deviations, discrepancies, and non-conformances related to validation activities and implement corrective and preventive actions (CAPAs) as necessary.
• Stay current on industry trends, regulatory changes, and best practices in validation engineering.

Benefits

• Paid time off
• Paid holidays
• Medical
• 401K match