Job description:
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.