Job Title: Validation Engineer
Job Summary:
The Validation Engineer plays a crucial role in ensuring that products and processes meet quality standards through testing, analyzing, and validating systems. They work closely with cross-functional teams to develop validation protocols and reports in accordance with regulatory requirements.
Responsibilities and Duties:
1. Develop validation protocols and reports for new and existing products.
2. Execute validation tests, analyze results, and provide recommendations for improvements.
3. Collaborate with design and manufacturing teams to ensure products comply with industry standards.
4. Identify and address any deviations or non-conformities in the validation process.
5. Maintain documentation and records for all validation activities.
6. Participate in design reviews and risk assessments to identify potential validation requirements.
7. Coordinate with external vendors and suppliers to ensure validation processes are completed accurately.
8. Keep up-to-date with industry trends and regulations related to validation engineering.
Qualifications and Skills:
1. Bachelor's degree in Engineering or related field.
2. Minimum of 2 years of experience in validation engineering.
3. Strong analytical and problem-solving skills.
4. Excellent communication and teamwork abilities.
5. Knowledge of regulatory requirements, such as FDA and ISO standards.
6. Proficiency in testing tools and statistical analysis software.
7. Detail-oriented and able to work under pressure.
8. Ability to multitask and prioritize tasks effectively.
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