Product Validation Specialist
3 days ago
We are seeking a detail-oriented and proactive engineer to support product development, equipment qualification, and site validation programs.
Key Responsibilities:
- Design, execute, and report on Process Performance Qualifications (PPQs).
- Conduct validation studies for equipment, systems, and processes.
- Ensure all validation activities meet regulatory requirements.
- Provide technical interpretation and guidance on FDA and EU validation guidelines.
- Maintain validation documentation throughout the lifecycle.
- Support change control processes and participate in inspections.
Requirements:
- 3-5 years' experience in a manufacturing environment.
- Degree in Science or Engineering.
- Strong technical knowledge of process development, validation, and pharmaceutical plants.
- Familiarity with cGMP, GAMP, ISPE, and validation standards.
- Excellent problem-solving skills and ability to troubleshoot challenges.
Benefits:
This role offers a unique opportunity to work in a dynamic team and contribute to the success of our organization. As a quality assurance professional, you will have the chance to develop your skills and expertise in a fast-paced environment.
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