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Manufacturing Engineer Position
2 weeks ago
Engineer Professional
Position OverviewWe are seeking an experienced and detail-oriented Engineer to join our organization in a vaccine manufacturing facility.
Main Responsibilities- Temperature Monitoring: Plan, execute, and document temperature mapping studies for storage areas and critical process equipment. Analyze data for compliance with EU GMP standards.
- Autoclave Load Qualification: Support the qualification of autoclaves, including moist heat sterilization cycles. Ensure Biological Indicators and thermocouples are placed per GMP requirements.
- Equipment Validation: Assist with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment.
- Cleanroom Support: Participate in routine cleanroom qualification activities, including HEPA integrity testing and airflow visualization.
- Bachelor's degree in Mechanical, Chemical, Biomedical, or Process Engineering.
- Familiarity with validation principles and GMP guidelines.
- Proficient with Microsoft Office.
- Excellent analytical mindset and willingness to learn.