
Engineer of Process Assurance
2 weeks ago
The role of a Validation Engineer involves ensuring the quality and reliability of pharmaceutical equipment, systems, and processes.
- Design and execute validation studies to test the performance of equipment, systems, and processes.
- Develop and maintain technical documentation to support validation activities.
- Analyze data from validation studies to identify areas for improvement.
- Collaborate with cross-functional teams to implement process improvements.
- Maintain regulatory compliance by adhering to FDA and EU guidelines.
Requirements:
- Bachelor's degree in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical/Mech/Elec).
- Previous experience in validation or product development is an asset.
- Familiarity with GAMP, ISPE Baseline guides, and relevant regulations.
- Strong understanding of quality management systems and communication skills.
- Proficiency in MS Project and SPC packages is an advantage.
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