Duties & Responsibilities:

• Manage qualification, validation, and calibration processes and protocols/reports (prepare, review, approve, execute) for plant and facility systems.
• Generate, review, and approve standard operating procedures (SOPs), risk assessment reports, and deviation reports.
• Ensure adherence to GMP/GLP compliance and data integrity guidelines.
• Collaborate with cross-functional teams to support validation activities and resolve any issues that arise.
• Conduct equipment validation activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Perform regular assessments and maintenance of validated systems to ensure continued compliance.
• Develop and maintain validation master plans and protocols for new equipment and systems.
• Provide training and support to staff on validation processes and equipment operation.
• Participate in audits and inspections related to validation activities.
• Analyze and document validation results, ensuring accurate reporting and compliance with regulatory standards.

Qualifications:

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, Mechatronics).
• 1.5 to 3 years of experience in a facilities or systems environment, performing analyses and working with relevant instrumentation.
• Strong knowledge of validation methodologies and regulatory requirements (e.g., FDA, WHO, ISPE, etc.).
• Familiarity with quality management systems and documentation practices.
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
• Proficiency in using validation tools and software.
• Proficiency in English, both written and spoken, is required.
• Certification in validation or quality assurance is a plus.