Validation Engineer

Key Responsibilities:

• Validation Protocols: Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and software systems to ensure compliance with FDA and ISO regulations.
• Documentation: Prepare and review validation documentation, including validation plans, test protocols, and final reports, ensuring accuracy and completeness.
• Risk Assessment: Conduct risk assessments to identify potential validation issues and develop appropriate mitigation strategies.
• Collaboration: Work closely with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure alignment on validation activities and compliance requirements.
• Troubleshooting: Investigate and resolve validation deviations and non-conformances, implementing corrective actions as necessary.
• Continuous Improvement: Identify opportunities for process improvements in validation practices and contribute to the development of best practices and standard operating procedures (SOPs).
• Training: Mentor and train junior validation engineers and other team members on validation principles, methodologies, and regulatory requirements.

Qualifications:

• Education: Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred.
• Experience: Minimum of 5 years of experience in validation within the medical device or pharmaceutical industry.
• Knowledge: Strong understanding of FDA regulations, ISO standards, and Good Manufacturing Practices (GMP).
• Skills: Proficient in validation methodologies and tools, with experience in statistical analysis and data interpretation.
• Communication: Excellent verbal and written communication skills, with the ability to present complex information clearly to diverse audiences.
• Problem-Solving: Strong analytical and problem-solving skills, with a detail-oriented approac