Description
Job Summary:
We are seeking a skilled Validation Engineer with a focus on utility and facility systems to join our team. The ideal candidate will be responsible for the qualification and validation of manufacturing environments, including but not limited to manufacturing rooms, process air systems, carbon dioxide systems, and HVAC systems. This role is critical in ensuring compliance with industry regulations and maintaining the integrity of our facility operations.
Key Responsibilities:
Validation Planning: Develop and execute validation strategies and protocols for utilities and facility systems, ensuring adherence to regulatory standards and company policies. Qualification Activities: Conduct qualification activities for manufacturing rooms, HVAC systems, process air, and carbon dioxide systems, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Documentation: Prepare and maintain validation documentation, including protocols, reports, and change control records, ensuring thorough documentation practices. System Monitoring: Implement monitoring systems to track the performance and reliability of utility systems, analyzing data to identify trends and potential issues. Regulatory Compliance: Ensure compliance with applicable regulations, including cGMP, FDA, and other industry standards, and keep abreast of changes in regulatory requirements. Risk Assessment: Perform risk assessments related to utility systems and processes, developing mitigation strategies as necessary. Collaboration: Work closely with cross-functional teams, including Operations, Quality Assurance, and Engineering, to support facility design, upgrades, and improvements. Training and Support: Provide training and support to staff on validation processes, system operation, and regulatory compliance as needed. Troubleshooting: Assist in troubleshooting utility system issues, conducting root cause analysis and implementing corrective actions. Qualifications: Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degree preferred. Minimum 5+ years of experience in validation engineering, with a focus on utility and facility systems in a regulated environment. Strong knowledge of validation principles and practices, including HVAC, process air, and gas systems. Familiarity with cGMP regulations and FDA guidelines. Excellent analytical and problem-solving skills, with the ability to work independently and as part of a team. Strong written and verbal communication skills, with attention to detail. Proficient in validation software and Microsoft Office Suite.
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