Validation Engineer

Summary:

We are seeking a talented Validation Engineer to join our team. As a Validation Engineer, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes and systems. You will be responsible for designing, implementing, and executing validation protocols to ensure that equipment, facilities, and processes meet regulatory requirements and industry standards.

Roles & Responsibilities:

• 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.

Education & Experience:

• Bachelor's degree in Engineering, Biology, Chemistry, or related field.
• Experience in validation engineering, preferably in the biopharmaceutical or pharmaceutical industry.
• Strong knowledge of validation principles, practices, and regulatory requirements, including FDA, EMA, and ICH guidelines.
• Experience with validation of equipment, utilities, facilities, and processes used in GMP manufacturing.
• Familiarity with risk assessment methodologies, statistical analysis, and validation documentation.
• Excellent analytical skills with attention to detail and accuracy.
• Strong communication and interpersonal skills, with the ability to collaborate effectively across functional teams.
• Ability to work independently and manage multiple projects simultaneously.
• Experience with computerized systems validation (CSV), specifically SCADA or PLC.