Requalification Engineer

Role Overview:

We are seeking an experienced Requalification Engineer to manage and execute periodic requalification activities for manufacturing equipment, facilities, and utility systems. The ideal candidate will ensure continued compliance with regulatory requirements and internal standards, supporting operational reliability and audit readiness.

Key Responsibilities:

• Develop, schedule, and execute requalification protocols for production equipment, cleanrooms, and utilities according to established intervals and compliance requirements.
• Prepare, review, and update requalification documentation—including protocols, reports, and change records.
• Perform equipment testing and data analysis in line with Installation (IQ), Operational (OQ), and Performance Qualification (PQ) frameworks.
• Coordinate requalification activities with engineering, maintenance, quality assurance, and production teams to minimize downtime and disruption.
• Investigate requalification deviations, support root cause analysis, and implement corrective actions (CAPA).
• Ensure ongoing compliance with GMP, FDA, ISO, and other applicable industry or regulatory standards.
• Participate in audits, inspections, and facilitate inspection readiness for requalification programs.
• Assess equipment modifications or upgrades to determine requalification requirements.
• Maintain accurate records and track requalification schedules using internal management systems.
• Train and support staff in requalification processes and compliance expectations.

Requirements:

• Bachelor’s or Master’s degree in Engineering (Mechanical, Electrical, Process), Life Sciences, or related field.
• [Insert Years] experience in equipment qualification, validation, or requalification within regulated manufacturing environments (pharma, biotech, food, medical device, etc.).
• In-depth knowledge of qualification and validation methodologies, regulatory requirements (GMP, FDA, ISO), and industry best practices.
• Strong project coordination, analytical, and problem-solving skills.
• Excellent documentation, report writing, and communication abilities.
• Experience in managing multiple qualification/requalification projects and working with cross-functional teams.