ESSENTIAL DUTIES AND RESPONSIBILITIES

• Design and execute qualification and validation tests, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) studies.
• Analyze validation data and results to assess the performance and reliability of manufacturing processes and equipment, identifying areas for improvement and optimization.
• Develop and maintain validation documentation, including validation protocols, reports, and validation master plans (VMPs), in compliance with regulatory requirements and company standards.

• Provide technical expertise and guidance to validation team members, ensuring validation activities are conducted by established protocols and procedures.
• Participate in risk assessments, root cause analysis, and deviation investigations related to validation activities, implementing corrective and preventive actions as needed.
• Collaborate with cross-functional teams, including engineering, quality assurance, and production, to coordinate validation activities and ensure alignment with project timelines and objectives.
• Uphold a culture of excellence, quality, and compliance in all validation activities, promoting a proactive approach to continuous improvement and innovation.

EXPERIENCE AND/OR EDUCATION

• Minimum of 5 years of experience in validation, quality assurance, or related field in a manufacturing environment.
• In-depth knowledge of validation principles, techniques, and regulatory requirements (e.g., FDA, ISO).
• Strong analytical skills with the ability to collect, analyze, and interpret complex data sets.
• Proficiency in validation documentation and record-keeping, including familiarity with document control systems and electronic data management systems.
• Foundational experience in one of the following disciplines

• Inside Manufacturing/Warehouse work
• No exposure to extreme weather
• Noise level moderate
• Ability to consistently lift <50lbs