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Senior Aseptic Processing Engineer
hace 21 horas
**Job Summary:**
We are seeking a highly skilled Senior Aseptic Processing Engineer to lead our efforts in designing, implementing, and improving aseptic processes and systems within a regulated pharmaceutical environment.
The ideal candidate will have expertise in aseptic processing, FDA product submissions, and validation activities. Key responsibilities include:
- Leading the design, implementation, and improvement of aseptic processes and systems
- Troubleshooting and resolving issues related to aseptic operations
- Supporting FDA submissions with technical expertise and documentation
- Developing, executing, and documenting validation protocols (IQ/OQ/PQ)
- Leading investigations for deviations and CAPAs related to aseptic operations
Requirements:
- Bachelor's or Master's Degree in Engineering, Pharmaceutical Sciences, or a related field
- Minimum of 5-7 years of experience in aseptic process engineering, equipment validation, and FDA product submissions
- Strong knowledge of aseptic processing and systems
- Expertise in validation methodologies (IQ/OQ/PQ) and risk management
- Familiarity with FDA regulations, cGMP guidelines, and industry standards
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