Validation Engineer
6 hours ago
Job Summary
We are looking for a Validation Engineer to join our Quality Validation team in Ipoh. The successful candidate will coordinate and execute qualification and validation activities to ensure compliance with cGMP standards and regulatory requirements. This role offers opportunities for technical growth, project leadership, and cross-functional collaboration within a dynamic pharmaceutical environment.
Key Responsibilities
- Coordinate qualification and requalification activities (IQ/OQ/PQ/CSV) for pharmaceutical facilities, critical utilities, and manufacturing equipment.
- Prepare and maintain qualification protocols, reports, and related documentation.
- Conduct training sessions for personnel on qualification and validation procedures.
- Ensure equipment, utilities, and systems are validated or revalidated according to schedule.
- Review test results for quality control, HEPA leak testing, and Compressed Dry Air (CDA) systems.
- Prepare and manage the qualification master plan and planner.
- Lead validation projects and teams, ensuring effective coordination with other departments.
- Perform quality risk assessments and participate in inter-departmental reviews.
- Analyze data and prepare comprehensive validation reports.
- Review and approve calibration certificates for compliance.
- Develop, revise, and implement Standard Operating Procedures (SOPs).
- Perform other related tasks as assigned by superiors.
Requirements
- Bachelor's Degree in Science, Engineering, Manufacturing Technology, or a related field.
- Minimum 1 year of relevant validation experience; 2 years in the pharmaceutical industry strongly preferred.
- Proven experience in process, equipment, and cleaning validation.
- Strong knowledge of cGMP and pharmaceutical validation practices.
- Excellent communication, interpersonal, and project management skills.
- Able to work independently and collaboratively in a fast-paced environment.
- Proactive, detail-oriented, and committed to continuous improvement.
Why Join Us?
- Opportunity to grow within a leading Malaysian pharmaceutical company.
- Exposure to cross-functional validation and quality projects.
- Supportive work culture that values teamwork, learning, and innovation.
- Competitive salary and benefits package.
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