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Product Validation Specialist
2 weeks ago
We are currently seeking a skilled and detail-oriented engineer to play a key role in supporting new product introductions, equipment qualification, and site requalification programs.
About the Role- Design, execute, and report on process performance qualifications (PPQ)
- Conduct validation studies for equipment, systems, and processes
The ideal candidate will have experience in a healthcare manufacturing environment and possess a strong technical knowledge of pharmaceutical plants, validation, and process development.
Key Responsibilities:- Develop and implement qualification protocols
- Maintain validation documentation throughout the lifecycle
- Ensure all validation activities comply with regulatory requirements
- 3-5 years experience in a healthcare manufacturing environment
- Degree in Science or Engineering
- Strong understanding of cGMP, GAMP, ISPE, FDA/EU guidelines, and validation standards
- Familiarity with industry trends and best practices
- Possesses excellent problem-solving and analytical skills